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 BEST PRACTICE GUIDELINES

 

MANAGEMENT OF CERVICAL CANCER

SUMMARY OF MAJOR RECOMMENDATIONS BASED ON SIGN GUIDELINE NO 99 (JANUARY 2008)

http://www.sign.ac.uk/pdf/qrg99.pdf

INTRODUCTION

 

Cervical cytology detects precancerous changes of the cervix known as cervical intraepithelial neoplasia (CIN). Population screening has been known to reduce the incidence of cervical cancer and reduce the proportion of women presenting with advanced disease. Only 30% of cervical cancers are screen detected and the majority of cases occur in women who have never had a smear or have not been regularly screened. Any woman who is sexually active is at risk of infection with Human Papilloma Virus (HPV). Over 100 subtypes of HPV are known, of which, subtypes 16 and 18 cause 70% of cervical cancer cases worldwide. Two HPV vaccines have been developed:

1) Cervarix a bivalent vaccine active against types 16 and 18

2) Gardasil a quadrivalent vaccine active against subtypes 6,11,16, 18.

Both are prophylactic vaccines that have been shown to be effective in young women who have not had HPV exposure.

 

This guideline covers presentation, referral, diagnosis, staging and treatment. The management of small cell and large cell neuroendocrine tumors is not included. The aim of this guideline is to ensure optimal management by a multidisciplinary team to minimize the huge burden experienced by women with the disease.

 

SUMMARY OF MAJOR RECOMMENDATIONS

 

PRESENTATION

 

·         Intermenstrual Bleeding (IMB)

·         Postcoital Bleeding (PCB)

·         Post menopausal bleeding (PMB)

·         Abnormal appearance of the cervix

·         Vaginal Discharge

·         Pelvic Pain

 

DIAGNOSIS AND SYMPTOMS

Pathology reports of cervical tumours should include the following histological features: D

·         Tumor type

·         Tumor size

·         Extent of tumor (e.g. involvement of the vaginal wall or parametrium)

·         Depth of invasion

·         Pattern of invasion (infiltrative or cohesive invasive front)

·         Lymphovascular space invasion (LVSI)

·         Status of resection margins (presence of tumor and distance from margin)

·         Status of lymph nodes (including site and number of nodes involved)

·         Presence of pre-invasive disease.

           

GOOD PRACTICE GUIDELINE

 

·         Pathological assessment should be quality assured and standardized, with readily accessible specialist review available if required, following discussion by the multidisciplinary team

 

RADIOLOGICAL STAGING

 

  • All patients with visible, biopsy proven cervical carcinoma (except those with FIGO IV disease) should have an MRI scan. B
  • The MRI scan should include: thin section T2 weighted images perpendicular to the cervix, and
  • sequences to include urinary tract and para-aortic nodal areas.               C
  • Post contrast spiral CT should be considered as an alternative to MRI in patients who cannot have MRI. Women who have clinically apparent FIGO stage IV disease should have post contrast spiral or multislice CT scans of chest abdomen and pelvis.                 B
  • Patients not suitable for surgery should be considered for a PET scan. C
  • If imaging cannot exclude bladder or bowel involvement, cystoscopy and sigmoidoscopy should be used for staging                C

 

SURGERY

  • Radical surgery is recommended for FIGO IB1 disease if there are no contraindications to surgery. B
  • Removal of pelvic lymph nodes is not recommended during treatment for FIGO IA1 disease. D
  • Pelvic lymph nodes should be removed if FIGO IA2 disease is present. D
  • Women requesting fertility conservation should be offered radical trachelectomy and pelvic lymph node dissection, providing the tumor diameter is less than 2 cm and no lymphatic-vascular space invasion is present. C
  • Women with early stage disease and no LVSI (FIGO IA2 and microscopic IB1) requesting fertility conservation may be offered cold knife conisation or large loop excision of the transformation zone combined with pelvic lymph node dissection. D
  • Laparoscopic-vaginal radical hysterectomy should not be offered to patients with tumor diameter greater than 2 cm. D

 

TREATMENT DURING PREGNANCY

 

  • For pregnant women with cervical cancer, the choice of therapeutic modality should be decided in the same manner as for non-pregnant patients. C
  • For pregnant women diagnosed with cervical cancer before 16 weeks of gestation, immediate treatment is recommended. C
  • For pregnant women with early stage disease (FIGO IA1, IA2, IB) diagnosed after 16 weeks of gestation, treatment may be delayed to allow fetal maturity to occur. C
  • For pregnant women with advanced disease (FIGO 1B2 or greater) diagnosed after 16 weeks of gestation, consideration for delay must be based on gestational age at time of diagnosis C

 

CHEMOTHERAPY/RADIOTHERAPY

 

·         Any patient with cervical cancer considered suitable for radical radiotherapy treatment should have concurrent chemoradiotherapy with a platinum based chemotherapy, if fit enough. A

·         Patients who have undergone surgery for cervical carcinoma and have positive nodes should be considered for adjuvant treatment with concurrent chemoradiotherapy with platinum based chemotherapy.             B

·         Patients who have undergone surgery for cervical carcinoma, have negative nodes and any two of the following risk factors should be considered for adjuvant treatment with radiotherapy, if fit enough:

1.     greater than a third stromal invasion

2.     Lymphovascular space invasion

3.     tumor diameter of >4 cm.      B

 

·         Concurrent chemoradiation should be considered in preference to radiation alone. D

·         Brachytherapy should be considered an essential component of radical radiotherapy or chemoradiotherapy. D

·         Patients with cervical carcinoma undergoing radiotherapy or chemoradiotherapy should have their hemoglobin level monitored and corrected if it falls below 12 g/dl. D

·         Rectal or oral sucralfate is not recommended to reduce acute radiation induced proctitis. B

·         Rectal sucralfate may be considered to reduce late radiation induced proctitis. D

·         HRT is recommended for women who have lost ovarian function as a result of treatment for cervical cancer. C

·         Sexual morbidity: Women should be offered a vaginal stent or dilator to prevent post-radiotherapy vaginal complications. C

 

LYMPHOEDEMA

·         Patients with symptoms suggestive of lymphoedema should be referred early for assessment by a designated lymphoedema practitioner. D

·         Patients with severe or poorly controlled lymphoedema should be offered decongestive lymphatic therapy with a specialist lymphoedema practitioner. D

 

FOLLOW-UP

 

GOOD PRACTICE GUIDELINE:

 

·         Patients should be followed up every four months for at least two years.               

·         History taking and clinical examination should be carried out during follow up of patients with cervical cancer to detect symptomatic and asymptomatic recurrence. D

·         Cervical cytology or vault smears are not indicated to detect asymptomatic recurrence of cervical cancer D.

               

Management of Minor Hemorrhage

 

Treatment for minor hemorrhage may include:

·         Oral tranexamic acid or aminocaproic acid

·         Tranexamic acid applied topically to superficial fungating wound tranexamic acid by rectal or bladder instillation a single fraction of radiotherapy D

 

DETECTION OF RECURRENT DISEASE

 

·         MRI or CT should be considered initially to assess potential clinical recurrence in symptomatic patients. C

·         A whole body PET scan or PET-CT should be performed on all patients in whom recurrent or persistent disease has been demonstrated on MRI or CT and in whom salvage therapy (either pelvic exenteration or radiotherapy) is being considered. B

 

GOOD PRACTICE GUIDELINE

·         A PET-CT scan at nine months of follow up is recommended in women who have had chemoradiotherapy

 

MANAGEMENT OF RECURRENT DISEASE

 

·         Pelvic exenteration should be reserved as salvage surgery for women with recurrent cervical cancer in the central pelvis whose chemoradiotherapy has failed.         D

·         Palliative chemotherapy should be offered to women with FIGO stage IVB or recurrent cervical carcinoma, after discussion of the relative benefits and risks, with either cisplatin 50 mg/m2 on day 1 plus topotecan 0.75 mg/m2 on days 1 to 3 every 3 weeks, or cisplatin 50 mg/m2 on day 1 plus paclitaxel 135 mg/m2 every 3 weeks.

 

 

SUPPORTIVE MANAGEMENT

·         Patients with cervical cancer should be offered psychological support at the time of diagnosis and at intervals throughout their management. B

·         Information about local support services should be made available to patients. D

·         Careers, families and dependants should be made aware of support available including local and national organizations. D

 

 

EVIDENCE BASED CARE: MANAGEMENT OF PRETERM LABOR

A compilation of recommendations from various bibliographic sources

 

INTRODUCTION

Preterm birth occurs in around 6% to 10% of birthsis the major complication of pregnancy associated with perinatal mortality and morbidity. Previous preterm delivery is a strong predictor for preterm labour, and the earlier the birth, the more likely it is to be repeated at the same gestation.

The following recommendations are based on good and consistent scientific evidence (Level A):

  • There are no clear "first-line" tocolytic drugs to manage preterm labor. Clinical circumstances and physician preferences should dictate treatment.
  • Antibiotics do not appear to prolong gestation and should be reserved for group B streptococcal prophylaxis in patients in whom delivery is imminent. There is no clear overall benefit from prophylactic antibiotic treatment for preterm labour with intact membranes on neonatal outcomes This treatment cannot therefore be currently recommended for routine practice.
  • Neither maintenance treatment with tocolytic drugs nor repeated acute tocolysis improve perinatal outcome; neither should be undertaken as a general practice.
  • Tocolytic drugs may prolong pregnancy for 2 to 7 days, which may allow for administration of steroids to improve fetal lung maturity and the consideration of maternal transport to a tertiary care facility.

The following recommendations are based on limited or inconsistent scientific evidence (Level B):

  • Cervical ultrasound examination and fetal fibronectin testing have good negative predictive value; thus, either approach or both combined may be helpful in determining which patients do not need tocolysis.
  • Amniocentesis may be used in women in preterm labor to assess fetal lung maturity and intra-amniotic infection.
  • Bed rest, hydration, and pelvic rest do not appear to improve the rate of preterm birth and should not be routinely recommended.
  • PROBIOTICS: Probiotics are defined as live micro-organisms which, when administered in an adequate amount, confer a health benefit on the host. They have been shown to displace and kill pathogens and modulate the immune response by interfering with the inflammatory cascade that leads to preterm labour and delivery. Although the use of probiotics appears to treat vaginal infections in pregnancy, there are currently insufficient data from trials to assess impact on preterm birth and its complications.

Benefits of Specific Medication

  • Antenatal corticosteroids significantly reduce the incidence and severity of neonatal respiratory distress syndrome. The incidence of intraventricular hemorrhage and necrotizing enterocolitis also are reduced by the use of antenatal corticosteroids.
  • Tocolytic drugs may prolong gestation for 2 to 7 days, which can provide time for administration of steroids and maternal transport to a facility with a neonatal intensive care unit.
  • Calcium channel Blockers: When tocolysis is indicated for women in preterm labour, calcium channel blockers are preferable to other tocolytic agents compared, to other agents. When compared with any other tocolytic agent (mainly betamimetics), calcium channel blockers reduced the number of women giving birth within seven days of receiving treatment (relative risk (RR) 0.76; 95% confidence interval (CI) 0.60 to 0.97) and prior to 34 weeks' gestation (RR 0.83; 95% CI 0.69 to 0.99). Calcium channel blockers also reduced the requirement for women to have treatment ceased for adverse drug reaction  the frequency of neonatal respiratory distress syndrome, necrotising enterocolitis, intraventricular haemorrhage  and neonatal jaundice
  • Oral Betamimetics: Available evidence does not support the use of oral betamimetics for maintenance therapy after threatened preterm labour.
  • Nitric Oxide donors: There is currently insufficient evidence to support the routine administration of nitric oxide donors in the treatment of threatened preterm labour
  • Magnesium Sulphate: Magnesium sulphate is ineffective at delaying birth or preventing preterm birth, and its use is associated with an increased mortality for the infant. The risk of death (fetal and paediatric) was higher for infants exposed to magnesium sulphate (RR 2.82, 95% CI 1.20-6.62, 7 trials, 727 infants). Any further trials should be of high quality large enough to assess serious morbidity and mortality, compare different dose regimens, and provide neurodevelopmental status of the child.
  • COX Inhibitors: There is insufficient information on which to base decisions about the role of COX inhibition for women in preterm labour.  
  • Screening for lower genital tract infection antenatal: There is evidence that infection screening and treatment programs in pregnant women may reduce preterm birth and preterm low birthweights.

POTENTIAL HARMS

Side Effects of Tocolytic Medication

Terbutaline

  • Maternal side effects: Cardiac or cardiopulmonary arrhythmias, pulmonary edema, myocardial ischemia, hypotension, tachycardia
  • Fetal and neonatal side effects: Fetal tachycardia, hyperinsulinemia, hyperglycemia, myocardial and septal hypertrophy, myocardial ischemia

Ritodrine

  • Maternal side effects: Metabolic hyperglycemia, hyperinsulinemia, hypokalemia, antidiuresis, altered thyroid function, physiologic tremor, palpitations, nervousness, nausea or vomiting, fever, hallucinations
  • Fetal and neonatal side effects: Neonatal tachycardia, hypoglycemia, hypocalcemia, hyperbilirubinemia, hypotension, intraventricular hemorrhage

Magnesium Sulfate

  • Maternal side effects: Flushing, lethargy, headache, muscle weakness, diplopia, dry mouth, pulmonary edema, cardiac arrest
  • Fetal and neonatal side effects: Lethargy, hypotonia, respiratory depression, demineralization with prolonged use

Calcium Channel Blockers

  • Maternal side effects: Flushing, headache, dizziness, nausea, transient hypotension. Caution should be used in patients with renal disease and hypotension when administering calcium channel blockers. In addition, concomitant use of calcium channel blockers and magnesium sulfate is potentially harmful and has resulted in cardiovascular collapse.
  • Fetal and neonatal side effects: None noted as yet

Indomethacin

  • Maternal side effects: Nausea, heartburn
  • Fetal and neonatal side effects: Constriction of ductus arteriosus, pulmonary hypertension, reversible decrease in renal function with oligohydramnios, intraventricular hemorrhage, hyperbilirubinemia, necrotizing enterocolitis

Note: Combining tocolytic drugs potentially increases maternal morbidity and should be used with caution

CONTRAINDICATIONS

  • Tocolysis. General contraindications for tocolysis include severe preeclampsia, placental abruption, intrauterine infection, lethal congenital or chromosomal abnormalities, advanced cervical dilatation, and evidence of fetal compromise or placental insufficiency.
  • Beta-mimetic. Contraindications include cardiac arrhythmias (for terbutaline) and poorly controlled thyroid disease and diabetes mellitus (for ritodrine).
  • Magnesium sulfate. Contraindications include myasthenia gravis.
  • Calcium channel blockers. Contraindications include cardiac disease; should not be used concomitantly with magnesium sulfate.
  • Prostaglandin synthetase inhibitors. Contraindications include significant renal or hepatic impairment (for indomethacin), active peptic ulcer disease (for ketorolac), coagulation disorders or thrombocytopenia, nonsteroidal anti-inflammatory drug (NSAID)-sensitive asthma, other sensitivity to NSAIDs (for sulindac).

 

Progesterone in the prevention of preterm birth

Intramuscular progesterone is associated with a reduction in the risk of preterm birth less than 37 weeks' gestation, and infant birthweight less than 2500 grams. However, other important maternal and infant outcomes have been poorly reported to date, with most outcomes reported from a single trial only (Meis 2003). It is unclear if the prolongation of gestation translates into improved maternal and longer-term infant health outcomes.

Women and their caregivers should be aware that a previous preterm labour and/or short cervix (< 15 mm at 22–26 weeks’ gestation) on transvaginal ultrasound could be used as an indication for progesterone therapy. The therapy should be started after 20 weeks’ gestation and stopped when the risk of prematurity is low. (I-A) On the basis of the data from the RCTs and meta-analysis, it is recommended that in cases where the clinician and the patient have opted for the use of progesterone the following dosages

should be used:

• For prevention of PTL in women with history of previous PTL:

17 alpha- hydroxyprogesterone 250 mg IM weekly (IB) or

progesterone 100 mg daily vaginally. (I-A)

• For prevention of PTL in women with short cervix of _ 15 mm

detected on transvaginal uktrasound at 22–26 weeks progesterone 200 mg daily vaginally. (I-A)

BIBLIOGRAPHIC SOURCE(S)

  • American College of Obstetricians and Gynecologists (ACOG). Management of preterm labor. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2003 May. 9 p. (ACOG practice bulletin; no. 43). [74 references]
  • The use of progesterone for prevention of preterm birth: SOGC Technical Update No 202 January 2008
  • King J, Flenady V. Prophylactic antibiotics for inhibiting preterm labour with intact membranes. Cochrane Database of Systematic Reviews 2002, Issue 4. Art. No.: CD000246. DOI: 10.1002/14651858.CD000246
  • Othman M, Neilson JP, Alfirevic Z. Probiotics for preventing preterm labour. Cochrane Database of Systematic Reviews 2007, Issue 1. Art. No.: CD005941. DOI: 10.1002/14651858.CD005941.pub2
  • Dodd JM, Flenady V, Cincotta R, Crowther CA. Prenatal administration of progesterone for preventing preterm birth. Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.: CD004947. DOI: 10.1002/14651858.CD004947.pub2.
  • Dodd JM, Crowther CA, Dare MR, Middleton P. Oral betamimetics for maintenance therapy after threatened preterm labour. Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.: CD003927. DOI: 10.1002/14651858.CD003927.pub2.
  • Doyle LW, Crowther CA, Middleton P, Marret S. Magnesium sulphate for women at risk of preterm birth for neuroprotection of the fetus. Cochrane Database of Systematic Reviews 2007, Issue 3. Art. No.: CD004661. DOI: 10.1002/14651858.CD004661.pub2.
  • Crowther CA, Hiller JE, Doyle LW. Magnesium sulphate for preventing preterm birth in threatened preterm labour. Cochrane Database of Systematic Reviews 2002, Issue 4. Art. No.: CD001060. DOI: 10.1002/14651858.CD001060
  • Stan C, Boulvain M, Hirsbrunner-Amagbaly P, Pfister R. Hydration for treatment of preterm labour. Cochrane Database of Systematic Reviews 2002, Issue 2. Art. No.: CD003096. DOI: 10.1002/14651858.CD003096
  • King J, Flenady V, Cole S, Thornton S. Cyclo-oxygenase (COX) inhibitors for treating preterm labour. Cochrane Database of Systematic Reviews 2005, Issue 2. Art. No.: CD001992. DOI: 10.1002/14651858.CD001992.pub2.
  • King JF, Flenady VJ, Papatsonis DNM, Dekker GA, Carbonne B. Calcium channel blockers for inhibiting preterm labour. Cochrane Database of Systematic Reviews 2003, Issue 1. Art. No.: CD002255. DOI: 10.1002/14651858.CD002255.
  • Sosa C, Althabe F, Belizán J, Bergel E. Bed rest in singleton pregnancies for preventing preterm birth. Cochrane Database of Systematic Reviews 2004, Issue 1. Art. No.: CD003581. DOI: 10.1002/14651858.CD003581.pub2.
  • Swadpanich U, Lumbiganon P, Prasertcharoensook W, Laopaiboon M. Antenatal lower genital tract infection screening and treatment programs for preventing preterm delivery. Cochrane Database of Systematic Reviews 2008, Issue 2. Art. No.: CD006178. DOI: 10.1002/14651858.CD006178.pub2.
     
 

Evidence-based guidelines for the investigation and medical treatment of recurrent miscarriage

 

Based on the Recommendation of the ESHRE Special Interest Group for Early Pregnancy (SIGEP) (2006)

 

And

 

RCOG green top guideline No. 17, (2003)

 

INTRODUCTION

 

Recurrent miscarriage (RM) is traditionally defined as three or more consecutive miscarriages occurring before 20 weeks post-menstruation (Stirrat, 1990; Berry et al., 1995; Bricker and Farquharson, 2002). Around 1% of fertile couples will experience recurrent early pregnancy losses (Berry et al., 1995). The risk of recurrence increases with the maternal age and number of successive losses (Brigham et al., 1999; Andersen et al., 2000). Many therapeutic approaches remain controversial, mainly because of wide variations in patient-selection criteria and treatment protocols. The small sizes of most individual studies, poor stratification bias and matching of cases and controls have limited the translation of results into clinical practice. New randomized controlled trials (RCTs) and meta-analyses have recently been published in the international literature. This has prompted the ESHRE Special Interest Group for Early Pregnancy (SIGEP) to update its protocol for the investigation and medical management of RM.

 

 I. Evidence-based investigations for couples presenting

with RM

 

Coagulation investigations

 

  • All women with a history of three or more early pregnancy losses, that is, before 10 weeks, or 1 or more unexplained deaths at 10 weeks of a morphologically normal fetus, or 1 or more premature births at 34 weeks with severe preeclampsia or placental insufficiency, should be offered a testing for lupus anticoagulant (LAC) and anticardiolipin antibodies (aCL), known collectively as antiphospholipid antibodies (APA), to exclude APS syndrome.

 

  • The role of inherited thrombophilia (Factor V Leiden deficiency, activated

protein C resistance, prothrombin G20210A and protein S deficiency) is not clear and larger epidemiological studies are clearly needed to justify testing couples with RM for inherited thrombophilia in routine clinical practice.

 

Endocrinologic investigations

 

  • Early epidemiological data have shown an association between RM and hypothyroidism or diabetes mellitus.

 

  • Obesity is associated with a statistically significant increased risk of first trimester and recurrent miscarriage.

 

  • Other endocrinologic disorders, including hypersecretion of LH, high androgen levels, hyperprolactinaemia and luteal phase defects (LPD) have been associated with RM. Current evidence suggest however, that, as is the case for hypothyroidism, infertility is more likely a problem than pregnancy loss.

 

Immunologic investigations

 

Testing of peripheral blood NK cells and Mannan-binding lectin (MBL) (a C-type lectin) should not be performed routinely in the evaluation of miscarriage in general and RM in particular, except in the setting of a clinical trial.

 

Parental cytogenetic investigation

 

The incidence of structural chromosome abnormalities, usually a balanced translocation is increased in couples with RM. All the four factors, namely low maternal age at second miscarriage, a history of three or more miscarriages, a history of two or more miscarriages in a brother or sister and a history of two or more miscarriages in the parents of either partner increase the probability of carrier status. It is thus advised to refer for parental karyotype only when the probability of carrier status is 2.2% or more. This risk calculation can be obtained from Probability tables (Franssen et al., 2005) recommended for this purpose.

 

Histopathological and cytogenetic investigations

 

Whilst it is routine practice to send products of conception for histological examination, mainly to exclude a gestational trophoblastic disorder, the usefulness of histopathogical investigation of placental and/or fetal tissue in RM on future pregnancy management for an individual couple remains to be determined.

 

Anatomical investigations

 

The prevalence and impact on reproduction of uterine malformations in the general population have not been clearly established even though using 3Dultrasound, it has been reported that women with a subseptate uterus have a higher incidence of first trimester loss, whereas women with an arcuate uterus have a greater proportion of

second trimester loss and preterm delivery (Woelfer et al.,2001).

 

 

Other investigations

  • Investigation for Hyperhomocystinemia remains technically difficult and should not be performed outside a specific clinical context.

 

  • Toxoplasmosis, Rubella, cytomegalovirus, herpes (TORCH) screen is therefore

of limited value in the investigation of RM, outside an acute infectious episode.

 

  • The association between miscarriage and ionizing radiation, organic solvents, alcohol, mercury and lead is confirmed, whilst an association to caffeine, hyperthermia and cigarette smoking is suspected (Gardella and Hill, 2000).

 

Table of recommendations for the testing of couple presenting with recurrent miscarriage

 

Basic investigations

Obstetric and family history, age, BMI, organic solvents, alcohol, mercury,

lead, caffeine, hyperthermia, smoking

Full blood count (blood sugar level and thyroid function tests)

Antiphospholipid antibodies (LAC and aLC)

Parental karyotype (after 2 miscarriages—see Table I)

Pelvic ultrasound (SIS) and/or hysterosalpingogram and hysteroscopy and

laparoscopy in case of inconclusive findings

Research investigations within the context of a trial

Feto-placental karyotypes

Testing of uterine and/or peripheral blood NK cells

Mannan-binding lectin (MBL) level

Luteal phase endometrial biopsy

Homocysteine/folic acid level

Thrombophilia screening

 

 

II. Evidence-based medical therapies for couples presenting with RM

 

Anticoagulants

 

  • The data on the use of anticoagulants for the treatment of RM in women without APS is too limited to recommend their routine use within this context (Di Nisio et al., 2005).
  • The possible relationship between aspirin in early pregnancy and congenital defects remains controversial. A recent meta-analysis has found that the overall risk of congenital malformations in offspring of women exposed to aspirin in early pregnancy is not significantly higher than that in control subjects (Kozer et al., 2002). However, a significant increase in the risk of fetal gastroschisis (odds ratio 2.37, 95% CI 1.44–3.88) was found.

 

Progestational agents

 

  • A recent systematic review found no evidence to support the routine use of progesterone in the first trimester to prevent miscarriage (Oates-Whitehead et al., 2005). The route of administration did not influence the results. All trials were more than 40 years old, and a modern prospective RCT of sufficient power to determine the efficacy of progesterone supplementation in women with RM is needed to confirm these results.

 

  • Overall, the use of progestational agents during the first and second trimester of pregnancy is not associated with adverse effects in mothers. However, Carmichael et al. (2005) have recently reported that maternal intake of progestins in early pregnancy is associated with an increased risk of hypospadia in the male offspring (odds ratio 3.7, 95% CI 2.3–6.0).

 

Immunosuppressant and immunomodulator agents

 

  • The use of intravenous immunoglobulin (IVIG), anti-TNF- α, glucocorticoids or cellular therapies in order to prevent or reduce an ‘excessive immune response’ and/or abrogate maternal– fetal incompatibility in women with RM remains controversial.

 

  • Anti-TNF-α agents have been reported to be associated with the development of granulomatous disease, lymphoma, systemic lupus erythematosus-like syndromes, congestive cardiac failure and demyelinating diseases (Claudepierre et al., 2005).

 

  • Multiple courses of glucocorticoids during pregnancy are associated with serious side effects including an increased risk of preterm birth because of premature rupture of membranes and the development of preeclampsia and gestational diabetes (Empson et al., 2002).

 

Other treatments

 

  • A small number of non-randomized studies have reported that psychological support, that is, tender loving care (TLC) in early pregnancy, decreases miscarriage rates in women with unexplained RM.

 

  • A recent meta-analysis has shown that taking vitamin supplements, alone or in combination with other vitamins, before conception or in early pregnancy does not change the risk of early or late miscarriage (Rumbold et al., 2005).

 

Table on Recommendations for Treatment of Recurrent Miscarriage

 

Established Treatment

Tender loving care (TLC) and health advices (diet, coffee, smoking and

alcohol)

Treatment requiring more RCTS

Aspirin and/or LMW heparins for women presenting with APS or

(multiple) inherited thrombophilias

Progesterone in women presenting with unexplained early and late RM

IVIG in women presenting with unexplained secondary RM or late RM

Folic acid in women presenting with hyperhomocysteinaemia

Immunization with third-party donor leukocyte

Treatment of no proven benefit

Immunization with paternal leukocytes or trophoblast membranes

Multivitamins supplementation

Treatment associated with more harm than benefit

Daily corticoids during the first half of pregnancy

 

Long-acting reversible contraception

the effective and appropriate use of long-acting reversible contraception

National Collaborating Centre for Women’s

and Children’s Health

Commissioned by the National Institute for

Health and Clinical Excellence

October 2005

 

RCOG

 

PART-I

 

SUMMARY OF RECOMMENDATIONS FOR USE OF IUCDs AND LNG(IUS)

 

INTRODUCTION

 

Intrauterine devices (IUDs) are small contraceptive devices inserted through the cervix and positioned in the cavity of the uterus. Copper-containing IUDs currently available in the UK include: U-shaped (Multiload Cu375, MultiSafe 375, Multi-Safe 375 Short Loop, Load 375); plain T-shaped (Nova-T 380, Neo-Safe T 380, UT 380, UT 380 Short, Flexi-T 300); banded Tshaped (T-Safe CU 380A, Flexi-T 380, TT 380 Slimline); and frameless (GyneFix). The TT 380 Slimline is licensed for 10 years of use, the T-Safe CU 380A for 8 years and the remaining available IUDs for 5 years of use. The available IUDs have copper on a plastic frame or a thread (frameless), with a small thread that protrudes through the cervical canal into the upper part of the vagina allowing easy removal. The tails also can be checked regularly by the wearer to ensure correct placement. It may occasionally require local anaesthesia and dilation of the cervical canal to aid insertion in nulliparous or perimenopausal women. IUDs vary in structural design and amount of copper.

 

  • The licensed duration of use for IUDs containing 380mm2 copper ranges from 5 to 10 years, depending on the type of device. [D]

  • Women who are aged 40 years or older at the time of IUD insertion may retain the device until they no longer require contraception, even if this is beyond the duration of the UK Marketing Authorisation. [D]

 

EFFECTIVENESS

 

  • Women using the Multiload Cu375 had a higher cumulative pregnancy rate (5.3%) when compared with women using TCu 380A (3.4%) for up to 10 years.

  • Women using Nova-T 380 had a cumulative pregnancy rate of under 2% for up to 5 years.

  •  There was no significant difference in cumulative pregnancy rates between the frameless devices (0% to 2%) and TCu 380A (0.3% to 1.6%) after 3 years of use.

  • Healthcare professionals should be aware that the most effective IUDs contain at least 380 mm2 of copper and have banded copper on the arms. This, together with the licensed duration of use, should be considered when deciding which IUD to use [B]

  • Women should be informed that the pregnancy rate associated with the use of IUDs containing 380mm2 copper is very low (fewer than 20 in 1000 over 5 years) [C]

 

EXPULSION RATES

 

  • The expulsion rates are lower with TCu 380A than Multiload Cu375 at 3 years (5.4% versus 6.5%) and at 10 years (11.2% versus 14.8%).

• The expulsion rates between TCu 380A (2.6%) and frameless IUDs (3.1%) are similar between 2 and 6 years. 

  • Women should be informed that IUDs may be expelled but that this occurs in fewer than 1 in 20 women in 5 years [C]

  • Women should be advised how to check for the presence of IUD threads and encouraged to do this regularly with the aim of recognising expulsion [D,GPP]

DISCONTINUATION

  • up to 50% of women stop using IUDs within 5 years

  • the most common reasons for discontinuation are unacceptable vaginal bleeding and pain[C]

ADVERSE EFFECTS

  • IUD use is associated with increased bleeding problems and dysmenorrhoea but 1 year after insertion there is no significant difference in the rates of problems comparing TCu 380A, Multiload Cu375 and MLCu380.

  • Women should be informed of the likelihood of heavier bleeding and/or dysmenorrhoea with IUD use [C]

  • NSAIDs and tranexamic acid are effective in the treatment of heavy bleeding with IUD use [B]

  • Women who find heavy bleeding associated with IUD use unacceptable may consider changing to a levonorgestrel intrauterine system (LNG-IUS) [D/GPP]

  • There is no evidence of significant weight change between IUD and IUS users in European studies.

  • Women should be informed that any changes in mood and libido are similar whether using IUDs or the IUS, and that the changes are small [C]

  • Women should be informed that the risk of ectopic pregnancy when using IUDs is lower than when using no contraception [D]

  • Women should be informed that the overall risk of ectopic pregnancy when using the IUD is very low, at about 1 in 1000 in 5 years [C]

  • If a woman becomes pregnant with the IUD in situ, the risk of ectopic pregnancy is about 1 in 20, and she should seek advice to exclude ectopic pregnancy [C]

  • Women should be informed that the risk of developing pelvic inflammatory disease following IUD insertion is very low (less than 1 in 100) in women who are at low risk of sexually transmitted infections (STIs) [C]

  • Women should be informed that the risk of uterine perforation at the time of IUD insertion is very low (less than 1 in 1000) [D]

  • Contraceptive care providers should be aware that the risk of perforation is related to the skill of the healthcare professional inserting the IUD [D/GPP]

IUCD AND PREGNANCY

Women with an intrauterine pregnancy with an IUD in situ should be advised to have the IUD removed before 12 completed weeks’ gestation, whether or not they intend to continue the pregnancy [D/GPP]

ASSESSMENT PRIOR TO INSERTION

Testing for the following infections should be undertaken before IUD insertion:

Chlamydia trachomatis in women at risk of STIs

Neisseria gonorrhoeae in women from areas where the disease is prevalent and who are at risk of STIs

• any STIs in women who request it  [D/GPP]

If testing for STIs is not possible, or has not been completed, prophylactic antibiotics should be given before IUD insertion in women at increased risks of STIs [D/GPP]

TIMING OF INSERTION

Healthcare professionals should be aware that, provided that it is reasonably certain that the woman is not pregnant, IUDs can be inserted:

• at any time during the menstrual cycle

• immediately after first- or second-trimester abortion, or at any time thereafter

• from 4 weeks post partum, irrespective of the mode of delivery.[D/GPP]

TRAINING OF HEALTHCARE PROFESSIONALS

IUDs should only be fitted by trained personnel with continuing experience of

inserting at least one IUD or one IUS a month [C]

CONTRAINDICATIONS

IUDs may be used by adolescents, but STI risk should be considered where relevant. [D/GPP]

Healthcare professionals should be aware that:

• IUD use is not contraindicated in nulliparous women of any age

• women of all ages may use IUDs [D/GPP]

IUD use is not contraindicated in women with diabetes

• emergency drugs including anti-epileptic medication should be available at the time of IUD insertion in a woman with epilepsy because there may be an increased risk of a seizure at the time of cervical dilation

• IUD use is a safe and effective method of contraception for women who are HIVpositive or have AIDS (safer sex using condoms should be encouraged in this group) [D/GPP]

FOLLOW-UP

A follow-up visit should be recommended after the first menses, or 3–6 weeks after insertion, to exclude infection, perforation or expulsion. Thereafter, a woman should be strongly encouraged to return at any time to discuss problems, if she wants to change her method of contraception, or if it is time to have the IUD removed [D/GPP]

 

Nice Guidelines for Diabetes in Pregnancy

Diabetes in Pregnancy

NICE clinical guideline 63

Diabetes in pregnancy: management of diabetes and its complications from pre-conception to the postnatal period

Ordering information

You can download the following documents from www.nice.org.uk/CG063

• The NICE guideline (this document) – all the recommendations.

• A quick reference guide – a summary of the recommendations for healthcare professionals.

• ‘Understanding NICE guidance’ – information for patients and carers.

 • The full guideline – all the recommendations, details of how they were developed, and reviews of the evidence they were based on.

For printed copies of the quick reference guide or ‘Understanding NICE guidance’, phone NICE publications on 0845 003 7783 or email publications@nice.org.uk and quote:

• N1484 (quick reference guide)

• N1485 (‘Understanding NICE guidance’).

NICE clinical guidelines are recommendations about the treatment and care of people with specific diseases and conditions in the NHS in England and Wales.

This guidance represents the view of the Institute, which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. The guidance does not, however, override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer and informed by the summary of product characteristics of any drugs they are considering.

National Institute for Health and Clinical Excellence

MidCity Place

71 High Holborn

London

WC1V 6NA

 

www.nice.org.uk

© National Institute for Health and Clinical Excellence, 2008. All rights reserved. This material may be freely reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the express written permission of the Institute.

Contents

 Introduction..                                                              

Woman- and baby-centred care.                                 

Key priorities for implementation..                               

1      Guidance.                                                          

1.1       Pre-conception care.                                      

1.2       Gestational diabetes.                                   

1.3       Antenatal care.                                            

1.4       Intrapartum care.                                         

1.5       Neonatal care.                                          

1.6       Postnatal care.                                         

2      Notes on the scope of the guidance.                

3      Implementation..                                             

4      Research recommendations.                          

4.1       Screening, diagnosis and treatment for gestational diabetes.           

4.2       Monitoring blood glucose and ketones during pregnancy.              

4.3       Management of diabetes during pregnancy.                                   

4.4       Monitoring fetal growth and well-being.                                        

4.5       Glycaemic control during labour and birth..                                  

5      Other versions of this guideline.                                                        

5.1       Full guideline.                                                                               

5.2       Quick reference guide.                                                                 

5.3       Understanding NICE guidance.                                                    

6      Related NICE guidance.                                                                  

7      Updating the guideline.                                                                   

Appendix A: The Guideline Development Group.                                    

Appendix B: The Guideline Review Panel  

Introduction

Diabetes is a disorder of carbohydrate metabolism that requires immediate changes in lifestyle. In its chronic forms, diabetes is associated with long-term vascular complications, including retinopathy, nephropathy, neuropathy and vascular disease. Approximately 650,000 women give birth in England and Wales each year, and 2–5% of pregnancies involve women with diabetes. Approximately 87.5% of pregnancies complicated by diabetes are estimated to be due to gestational diabetes (which may or may not resolve after pregnancy), with 7.5% being due to type 1 diabetes and the remaining 5% being due to type 2 diabetes. The prevalence of type 1 and type 2 diabetes is increasing. In particular, type 2 diabetes is increasing in certain minority ethnic groups (including people of African, black Caribbean, South Asian, Middle Eastern and Chinese family origin).

Diabetes in pregnancy is associated with risks to the woman and to the developing fetus. Miscarriage, pre-eclampsia and preterm labour are more common in women with pre-existing diabetes. In addition, diabetic retinopathy can worsen rapidly during pregnancy. Stillbirth, congenital malformations, macrosomia, birth injury, perinatal mortality and postnatal adaptation problems (such as hypoglycaemia) are more common in babies born to women with pre-existing diabetes.

This clinical guideline contains recommendations for the management of diabetes and its complications in women who wish to conceive and those who are already pregnant. The guideline builds on existing clinical guidelines for routine care during the antenatal, intrapartum and postnatal periods. It focuses on areas where additional or different care should be offered to women with diabetes and their newborn babies.
 

Where the evidence supports it, the guideline makes separate recommendations for women with pre-existing diabetes (type 1 diabetes, type 2 diabetes and other forms of diabetes, such as maturity onset diabetes of the young) and gestational diabetes. The term 'women' is used in the guideline to refer to all females of childbearing age, including young women who have not yet transferred from paediatric to adult services.

The guideline will assume that prescribers will use a drug’s summary of product characteristics to inform their decisions for individual women.

Insulin aspart has marketing authorisation specifically for pregnant women. At the time of publication (March 2008), none of the other drugs recommended in the guideline have UK marketing authorisation specifically for pregnant women. Informed consent should be obtained and documented.

Woman- and baby-centred care

This guideline offers best practice advice on the care of women with diabetes who are planning to become pregnant, or who are already pregnant, and their newborn babies.

Treatment and care should take into account women’s needs and preferences. Women with diabetes should have the opportunity to make informed decisions about their care and treatment, in partnership with their healthcare professionals. If women do not have the capacity to make decisions, healthcare professionals should follow the Department of Health guidelines – ‘Reference guide to consent for examination or treatment’ (2001). Healthcare professionals should also follow a code of practice accompanying the Mental Capacity Act (summary available from www.publicguardian.gov.uk).

Good communication between healthcare professionals and women is essential. It should be supported by evidence-based written information tailored to the woman's needs. Treatment and care, and the information women are given about it, should be culturally appropriate. It should also be accessible to women with additional needs such as physical, sensory or learning disabilities, and to women who do not speak or read English.

Care of young women in transition between paediatric and adult services should be planned and managed according to the best practice guidance described in ‘Transition: getting it right for young people’ (available from www.dh.gov.uk). Adult and paediatric healthcare teams should work jointly to provide care for young women with diabetes.

Key priorities for implementation

Pre-conception care

·      Women with diabetes who are planning to become pregnant should be informed that establishing good glycaemic control before conception and continuing this throughout pregnancy will reduce the risk of miscarriage, congenital malformation, stillbirth and neonatal death. It is important to explain that risks can be reduced but not eliminated.

·      The importance of avoiding unplanned pregnancy should be an essential component of diabetes education from adolescence for women with diabetes.

·      Women with diabetes who are planning to become pregnant should be offered pre-conception care and advice before discontinuing contraception.

Antenatal care

·      If it is safely achievable, women with diabetes should aim to keep fasting blood glucose between 3.5 and 5.9 mmol/litre and 1-hour postprandial blood glucose below 7.8 mmol/litre during pregnancy.

·      Women with insulin-treated diabetes should be advised of the risks of hypoglycaemia and hypoglycaemia unawareness in pregnancy, particularly in the first trimester.

·      During pregnancy, women who are suspected of having diabetic ketoacidosis should be admitted immediately for level 2 critical care[1], where they can receive both medical and obstetric care.

·      Women with diabetes should be offered antenatal examination of the four-chamber view of the fetal heart and outflow tracts at 18–20 weeks.

 Level 2 critical care is defined as care for patients requiring detailed observation or intervention, including support for a single failing organ system or postoperative care and those ‘stepping down’ from higher levels of care.

Neonatal care

·      Babies of women with diabetes should be kept with their mothers unless there is a clinical complication or there are abnormal clinical signs that warrant admission for intensive or special care.

Postnatal care

·      Women who were diagnosed with gestational diabetes should be offered lifestyle advice (including weight control, diet and exercise) and offered a fasting plasma glucose measurement (but not an oral glucose tolerance test) at the 6-week postnatal check and annually thereafter.

1                                Guidance

The following guidance is based on the best available evidence. The full guideline gives details of the methods and the evidence used to develop the guidance.

1.1                         Pre-conception care

1.1.1                    Outcomes and risks for the woman and baby

1.1.1.1              Healthcare professionals should seek to empower women with diabetes to make the experience of pregnancy and childbirth a positive one by providing information, advice and support that will help to reduce the risks of adverse pregnancy outcomes for mother and baby.

1.1.1.2              Women with diabetes who are planning to become pregnant should be informed that establishing good glycaemic control before conception and continuing this throughout pregnancy will reduce the risk of miscarriage, congenital malformation, stillbirth and neonatal death. It is important to explain that risks can be reduced but not eliminated.

1.1.1.3              Women with diabetes who are planning to become pregnant and their families should be offered information about how diabetes affects pregnancy and how pregnancy affects diabetes. The information should cover:

·      the role of diet, body weight and exercise

·      the risks of hypoglycaemia and hypoglycaemia unawareness during pregnancy

·      how nausea and vomiting in pregnancy can affect glycaemic control

·      the increased risk of having a baby who is large for gestational age, which increases the likelihood of birth trauma, induction of labour and caesarean section

·      the need for assessment of diabetic retinopathy before and during pregnancy

·      the need for assessment of diabetic nephropathy before pregnancy

·      the importance of maternal glycaemic control during labour and birth and early feeding of the baby in order to reduce the risk of neonatal hypoglycaemia

·      the possibility of transient morbidity in the baby during the neonatal period, which may require admission to the neonatal unit

·      the risk of the baby developing obesity and/or diabetes in
later life.

1.1.2  The importance of planning pregnancy and the role of contraception

The importance of avoiding unplanned pregnancy should be an essential component of diabetes education from adolescence for women with diabetes.

Women with diabetes who are planning to become pregnant should be advised:

·      that the risks associated with pregnancies complicated by diabetes increase with the duration of diabetes

·      to use contraception until good glycaemic control (assessed by HbA1c[1]) has been established

·      that glycaemic targets, glucose monitoring, medications for diabetes (including insulin regimens for insulin-treated diabetes) and medications for complications of diabetes will need to be reviewed before and during pregnancy

 Diabetes Control and Complications Trial (DCCT)-aligned haemoglobin A1c (HbA1c) test.

·      that additional time and effort is required to manage diabetes during pregnancy and that there will be frequent contact with healthcare professionals. Women should be given information about the local arrangements for support, including emergency contact numbers.

1.1.3 Diet, dietary supplements, body weight and exercise

1.1.3.1   Women with diabetes who are planning to become pregnant should be offered individualised dietary advice.

1.1.3.2 Women with diabetes who are planning to become pregnant and who have a body mass index above 27 kg/m2 should be offered advice on how to lose weight in line with ‘Obesity: guidance on the prevention, identification, assessment and management of overweight and obesity in adults and children’

1.1.3.3 Women with diabetes who are planning to become pregnant should be advised to take folic acid (5 mg/day) until 12 weeks of gestation to reduce the risk of having a baby with a neural tube defect.

1.1.4 Target ranges for blood glucose in the pre-conception period

1.1.4.1 Individualized targets for self-monitoring of blood glucose should be agreed with women who have diabetes and are planning to become pregnant, taking into account the risk of hypoglycaemia.

1.1.4.2 If it is safely achievable, women with diabetes who are planning to become pregnant should aim to maintain their HbA1c below 6.1%. Women should be reassured that any reduction in HbA1c towards the target of 6.1% is likely to reduce the risk of congenital malformations.

1.1.4.3 Women with diabetes whose HbA1c is above 10% should be strongly advised to avoid pregnancy.

1.1.5 Monitoring blood glucose and ketones in the pre-conception period

1.1.5.1  Women with diabetes who are planning to become pregnant should be offered monthly measurement of HbA1c.

1.1.5.2 Women with diabetes who are planning to become pregnant should be offered a meter for self-monitoring of blood glucose.

1.1.5.3 Women with diabetes who are planning to become pregnant and who require intensification of hypoglycaemic therapy should be advised to increase the frequency of self-monitoring of blood glucose to include fasting and a mixture of pre- and postprandial levels.

1.1.5.4 Women with type 1 diabetes who are planning to become pregnant should be offered ketone testing strips and advised to test for ketonuria or ketonaemia if they become hyperglycemic or unwell.

1.1.6 The safety of medications for diabetes before and during pregnancy

1.1.6.1 Women with diabetes may be advised to use metformin* as an adjunct or alternative to insulin in the pre-conception period and during pregnancy, when the likely benefits from improved glycaemic control outweigh the potential for harm. All other oral hypoglycaemic agents should be discontinued before pregnancy and insulin substituted.

1.1.6.2    Healthcare professionals should be aware that the rapid-acting insulin analogues are safe to use during pregnancy.

1.1.6.3 Women with insulin-treated diabetes who are planning to become pregnant should be informed that there is insufficient evidence about the use of long-acting insulin analogues during pregnancy. Therefore isophane insulin* (also known as NPH insulin) remains the first choice for long-acting insulin during pregnancy.

1.1.7 The safety of medications for diabetic complications before and during pregnancy

1.1.7.1 Angiotensin-converting enzyme inhibitors and angiotensin-II receptor antagonists should be discontinued before conception or as soon as pregnancy is confirmed. Alternative antihypertensive agents suitable for use during pregnancy should be substituted.

1.1.7.2 Statins should be discontinued before pregnancy or as soon as pregnancy is confirmed.

1.1.8 Removing barriers to the uptake of pre-conception care and when to offer information

1.1.8.1 Women with diabetes should be informed about the benefits of
pre-conception glycaemic control at every contact with healthcare professionals, including their diabetes care team, from adolescence.

1.1.8.2 The intentions of women with diabetes regarding pregnancy and contraceptive use should be documented at each contact with their diabetes care team from adolescence.

1.1.8.3 Pre-conception care for women with diabetes should be given in a supportive environment and the woman’s partner or other family member should be encouraged to attend.

1.1.Self-management programmes

1.1.9.1  Women with diabetes who are planning to become pregnant should be offered a structured education programme as soon as possible if they have not already attended one (see ‘Guidance on the use of patient-education models for diabetes’.

1.1.9.2  Women with diabetes who are planning to become pregnant
should be offered pre-conception care and advice before discontinuing contraception.

1.1.10   Retinal assessment in the pre-conception period

1.1.10.1 Women with diabetes seeking pre-conception care should be offered retinal assessment as detailed in recommendation 1.1.10.2 at their first appointment (unless an annual retinal assessment has occurred within the previous 6 months) and annually thereafter if no diabetic retinopathy is found.

1.1.10.2    Retinal assessment should be carried out by digital imaging with mydriasis using tropicamide*, in line with the UK National Screening Committee’s recommendations for annual mydriatic
two-field digital photographic screening as part of a systematic screening programme.

1.1.10.3 Women with diabetes who are planning to become pregnant should be advised to defer rapid optimization of glycaemic control until after retinal assessment and treatment have been completed.

1.1.11Renal assessment in the pre-conception period

1.1.11.1 Women with diabetes should be offered a renal assessment, including a measure of microalbuminuria, before discontinuing contraception. If serum creatinine is abnormal (120 micromol/litre or more) or the estimated glomerular filtration rate (eGFR) is less than 45 ml/minute/1.73 m2, referral to a nephrologist should be considered before discontinuing contraception.

1.2  Gestational diabetes

1.2.1 Risk factors for gestational diabetes

1.2.1.1 Healthcare professionals should be aware that the following have been shown to be independent risk factors for gestational diabetes:

·      body mass index above 30 kg/m2

·      previous macrosomic baby weighing 4.5 kg or above

·      previous gestational diabetes

·      family history of diabetes (first-degree relative with diabetes)

·      family origin with a high prevalence of diabetes:

-     South Asian (specifically women whose country of family origin is India, Pakistan or Bangladesh)

-     black Caribbean

-     Middle Eastern (specifically women whose country of family origin is Saudi Arabia, United Arab Emirates, Iraq, Jordan, Syria, Oman, Qatar, Kuwait, Lebanon or Egypt).

1.2.2 Screening, diagnosis and treatment for gestational diabetes

The following recommendations, numbered 1.2.2.1, 1.2.2.2 and 1.2.2.3, are taken from ‘Antenatal care: routine care for the healthy pregnant woman’ (NICE clinical guideline 62),

1.2.2.1 Screening for gestational diabetes using risk factors is recommended in a healthy population. At the booking
appointment, the following risk factors for gestational diabetes should be determined:

·      body mass index above 30 kg/m2

·      previous macrosomic baby weighing 4.5 kg or above

·      previous gestational diabetes

·      family history of diabetes (first-degree relative with diabetes)

·      family origin with a high prevalence of diabetes:

-     South Asian (specifically women whose country of family origin is India, Pakistan or Bangladesh)

-     black Caribbean

-             Middle Eastern (specifically women whose country of family origin is Saudi Arabia, United Arab Emirates, Iraq, Jordan, Syria, Oman, Qatar, Kuwait, Lebanon or Egypt). 

Women with any one of these risk factors should be offered testing for gestational diabetes (see recommendation 1.2.2.4).

1.2.2.2  In order to make an informed decision about screening and testing for gestational diabetes, women should be informed that:

·      in most women, gestational diabetes will respond to changes in diet and exercise

·      some women (between 10% and 20%) will need oral hypoglycaemic agents or insulin therapy if diet and exercise are not effective in controlling gestational diabetes

·      if gestational diabetes is not detected and controlled there is a small risk of birth complications such as shoulder dystocia

·      a diagnosis of gestational diabetes may lead to increased monitoring and interventions during both pregnancy and labour.

1.2.2.3  Screening for gestational diabetes using fasting plasma glucose, random blood glucose, glucose challenge test and urinalysis for glucose should not be undertaken.

1.2.2.4 The 2-hour 75 g oral glucose tolerance test (OGTT) should be used to test for gestational diabetes and diagnosis made using the criteria defined by the World Health Organization[1]. Women who have had gestational diabetes in a previous pregnancy should be offered early self-monitoring of blood glucose or an OGTT at
16–18 weeks, and a further OGTT at 28 weeks if the results are normal. Women with any of the other risk factors for gestational diabetes (see recommendation 1.2.2.1) should be offered an OGTT at 24–28 weeks.

1.2.2.5 Women with gestational diabetes should be instructed in self-monitoring of blood glucose. Targets for blood glucose control should be determined in the same way as for women with pre-existing diabetes.

1.2.2.6 Women with gestational diabetes should be informed that good glycaemic control throughout pregnancy will reduce the risk of fetal macrosomia, trauma during birth (to themselves and the baby), induction of labour or caesarean section, neonatal hypoglycaemia and perinatal death.

1.2.2.7  Women with gestational diabetes should be offered information covering:

·      the role of diet, body weight and exercise

·      the increased risk of having a baby who is large for gestational age, which increases the likelihood of birth trauma, induction of labour and caesarean section

·      the importance of maternal glycaemic control during labour and birth and early feeding of the baby in order to reduce the risk of neonatal hypoglycaemia

·      the possibility of transient morbidity in the baby during the neonatal period, which may require admission to the
neonatal unit

·      the risk of the baby developing obesity and/or diabetes in
later life.

1.2.2.8 Women with gestational diabetes should be advised to choose, where possible, carbohydrates from low glycaemic index sources, lean proteins including oily fish and a balance of polyunsaturated fats and monounsaturated fats.

1.2.2.9 Women with gestational diabetes whose pre-pregnancy body mass index was above 27 kg/m2 should be advised to restrict calorie intake (to 25 kcal/kg/day or less) and to take moderate exercise (of at least 30 minutes daily).

1.2.2.10 Hypoglycaemic therapy should be considered for women with gestational diabetes if diet and exercise fail to maintain blood glucose targets during a period of 1–2 weeks.

1.2.2.11 Hypoglycaemic therapy should be considered for women with gestational diabetes if ultrasound investigation suggests incipient fetal macrosomia (abdominal circumference above the 70th percentile) at diagnosis.

1.2.2.12 Hypoglycaemic therapy for women with gestational diabetes (which may include regular insulin*, rapid-acting insulin analogues  and/or oral hypoglycaemic agents [metformin* and glibenclamide*]) should be tailored to the glycaemic profile of, and acceptability to, the individual woman.

[1] Fasting plasma venous glucose concentration greater than or equal to 7.0 mmol/litre or 2-hour plasma venous glucose concentration greater than or equal to 7.8 mmol/litre. World Health Organization Department of Noncommunicable Disease Surveillance (1999) Definition, diagnosis and classification of diabetes mellitus and its complications. Report of a WHO consultation. Part 1: diagnosis and classification of diabetes mellitus. Geneva: World Health Organization.

1.3    Antenatal care

1.3.1 Target ranges for blood glucose during pregnancy

1.3.1.1 Individualized targets for self-monitoring of blood glucose should be agreed with women with diabetes in pregnancy, taking into account the risk of hypoglycaemia.

1.3.1.2  If it is safely achievable, women with diabetes should aim to keep fasting blood glucose between 3.5 and 5.9 mmol/litre and 1-hour postprandial blood glucose below 7.8 mmol/litre during pregnancy.

1.3.1.3 HbA1c should not be used routinely for assessing glycaemic control in the second and third trimesters of pregnancy.

1.3.21.1.2 Monitoring blood glucose and ketones during pregnancy

1.3.2.1 Women with diabetes should be advised to test fasting blood glucose levels and blood glucose levels 1 hour after every meal during pregnancy.

1.3.2.2 Women with insulin-treated diabetes should be advised to test blood glucose levels before going to bed at night during pregnancy.

1.3.2.3 Women with type 1 diabetes who are pregnant should be offered ketone testing strips and advised to test for ketonuria or ketonaemia if they become hyperglycemic or unwell.

1.3.3 Management of diabetes during pregnancy

1.3.3.1 Healthcare professionals should be aware that the rapid-acting insulin analogues have advantages over soluble human insulin* during pregnancy and should consider
their use.

1.3.3.2 Women with insulin-treated diabetes should be advised of the risks of hypoglycaemia and hypoglycaemia unawareness in pregnancy, particularly in the first trimester.

1.3.3.3 During pregnancy, women with insulin-treated diabetes should be provided with a concentrated glucose solution and women with type 1 diabetes should also be given glucagon; women and their partners or other family members should be instructed in their use.

1.3.3.4 During pregnancy, women with insulin-treated diabetes should
be offered continuous subcutaneous insulin infusion (CSII or
insulin pump therapy) if adequate glycaemic control is not
obtained by multiple daily injections of insulin without significant disabling hypoglycaemia[1].

1.3.3.5 During pregnancy, women with type 1 diabetes who become unwell should have diabetic ketoacidosis excluded as a matter of urgency.

1.3.3.6During pregnancy, women who are suspected of having diabetic ketoacidosis should be admitted immediately for level 2 critical care[2], where they can receive both medical and obstetric care.

[1] For the purpose of this guidance, ‘disabling hypoglycaemia’ means the repeated and unpredicted occurrence of hypoglycaemia requiring third-party assistance that results in continuing anxiety about recurrence and is associated with significant adverse effect on quality of life.

[2] Level 2 critical care is defined as care for patients requiring detailed observation or intervention, including support for a single failing organ system or postoperative care and those 'stepping down' from higher levels of care.

1.3.4 Retinal assessment during pregnancy

1.3.4.1Pregnant women with pre-existing diabetes should be offered retinal assessment by digital imaging with mydriasis using tropicamide* following their first antenatal clinic appointment and again at 28 weeks if the first assessment is normal. If any diabetic retinopathy is present, an additional retinal assessment should be performed at 16–20 weeks.

1.3.4.2 If retinal assessment has not been performed in the preceding 12 months, it should be offered as soon as possible after the first contact in pregnancy in women with pre-existing diabetes.

1.3.4.3Diabetic retinopathy should not be considered a contraindication to rapid optimization of glycaemic control in women who present with a high HbA1c in early pregnancy.

1.3.4.4Women who have preproliferative diabetic retinopathy diagnosed during pregnancy should have ophthalmological follow-up for at least 6 months following the birth of the baby.

1.3.4.5 Diabetic retinopathy should not be considered a contraindication to vaginal birth.

1.3.5Renal assessment during pregnancy

1.3.5.1If renal assessment has not been undertaken in the preceding 12 months in women with pre-existing diabetes, it should be arranged at the first contact in pregnancy. If serum creatinine
is abnormal (120 micromol/litre or more) or if total protein
excretion exceeds 2 g/day, referral to a nephrologist should be considered (eGFR should not be used during pregnancy). Thromboprophylaxis should be considered for women with proteinuria above 5 g/day (macroalbuminuria).

1.3.6 Screening for congenital malformations

1.3.6.1 Women with diabetes should be offered antenatal examination of the four-chamber view of the fetal heart and outflow tracts at
18–20 weeks.

1.3.7  Monitoring fetal growth and well-being

1.3.7.1 Pregnant women with diabetes should be offered ultrasound monitoring of fetal growth and amniotic fluid volume every 4 weeks from 28 to 36 weeks.

1.3.7.2 Routine monitoring of fetal well-being before 38 weeks is not recommended in pregnant women with diabetes, unless there is a risk of intrauterine growth restriction.

1.3.7.3 Women with diabetes and a risk of intrauterine growth restriction (macrovascular disease and/or nephropathy) will require an individualised approach to monitoring fetal growth and well-being.

1.3.8 Timetable of antenatal appointments

1.3.8.1 Women with diabetes who are pregnant should be offered immediate contact with a joint diabetes and antenatal clinic.

1.3.8.2 Women with diabetes should have contact with the diabetes care team for assessment of glycaemic control every 1–2 weeks throughout pregnancy.

1.3.8.3 Antenatal appointments for women with diabetes should provide care specifically for women with diabetes, in addition to the care provided routinely for healthy pregnant women (see ‘Antenatal care: routine care for the healthy pregnant woman’ [NICE clinical guideline 62], Table 1 describes where care for women with diabetes differs from routine antenatal care. At each appointment women should be offered ongoing opportunities for information and education.

* In this guideline, drug names are marked with an asterisk if they do not have UK marketing authorisation specifically for pregnant and breastfeeding women at the time of publication (March 2008). Informed consent should be obtained and documented.

Table 1 Specific antenatal care for women with diabetes

Appointment

Care for women with diabetes during pregnancya

First appointment (joint diabetes and antenatal clinic)

Offer information, advice and support in relation to optimizing glycaemic control.

Take a clinical history to establish the extent of diabetes-related complications.

Review medications for diabetes and its complications.

Offer retinal and/or renal assessment if these have not been undertaken in the previous 12 months.

7–9 weeks

Confirm viability of pregnancy and gestational age.

Booking appointment (ideally by 10 weeks)

Discuss information, education and advice about how diabetes will affect the pregnancy, birth and early parenting (such as breastfeeding and initial care of the baby).

16 weeks

Offer retinal assessment at 16–20 weeks to women with pre-existing diabetes who showed signs of diabetic retinopathy at the first antenatal appointment.

20 weeks

Offer four-chamber view of the fetal heart and outflow tracts plus scans that would be offered at 18–20 weeks as part of routine antenatal care.

28 weeks

Offer ultrasound monitoring of fetal growth and amniotic fluid volume.

Offer retinal assessment to women with pre-existing diabetes who showed no diabetic retinopathy at their first antenatal clinic visit.

32 weeks

Offer ultrasound monitoring of fetal growth and amniotic fluid volume.

Offer to nulliparous women all investigations that would be offered at 31 weeks as part of routine antenatal care.

36 weeks

Offer ultrasound monitoring of fetal growth and amniotic fluid volume.

Offer information and advice about:

·      timing, mode and management of birth

·      analgesia and anesthesia

·      changes to hypoglycaemic therapy during and after birth

·      management of the baby after birth

·      initiation of breastfeeding and the effect of breastfeeding on glycaemic control

·      contraception and follow-up.

38 weeks

Offer induction of labour, or caesarean section if indicated, and start regular tests of fetal well-being for women with diabetes who are awaiting spontaneous labour.

39 weeks

Offer tests of fetal well-being.

40 weeks

Offer tests of fetal well-being.

41 weeks

Offer tests of fetal well-being.

aWomen with diabetes should also receive routine care according to the schedule of appointments in ‘Antenatal care: routine care for the healthy pregnant woman’ (NICE clinical guideline 62), including appointments at 25 weeks (for nulliparous women) and 34 weeks, but with the exception of the appointment for nulliparous women at 31 weeks

1.3.9 Preterm labour in women with diabetes

1.3.9.1 Diabetes should not be considered a contraindication to antenatal steroids for fetal lung maturation or to tocolysis.

1.3.9.2 Women with insulin-treated diabetes who are receiving steroids for fetal lung maturation should have additional insulin according to an agreed protocol and should be closely monitored.

1.3.9.3 Betamimetic drugs should not be used for tocolysis in women
with diabetes.

1.4       Intrapartum care

This section should be read in conjunction with ‘Intrapartum care: care of healthy women and their babies during childbirth’ (NICE clinical guideline 55),This guideline includes information on timing and mode of birth for uncomplicated births at term.

1.4.1 Timing and mode of birth

1.4.1.1 Pregnant women with diabetes who have a normally grown fetus should be offered elective birth through induction of labour, or by elective caesarean section if indicated, after 38 completed weeks.

1.4.1.2 Diabetes should not in itself be considered a contraindication to attempting vaginal birth after a previous caesarean section.

1.4.1.3 Pregnant women with diabetes who have an ultrasound-diagnosed macrosomic fetus should be informed of the risks and benefits of vaginal birth, induction of labour and caesarean section.

1.4.2 Analgesia and anaesthesia

1.4.2.1 Women with diabetes and comorbidities such as obesity or autonomic neuropathy should be offered an anesthetic assessment in the third trimester of pregnancy. 

1.4.2.2 If general anesthesia is used for the birth in women with diabetes, blood glucose should be monitored regularly (every 30 minutes) from induction of general anesthesia until after the baby is born and the woman is fully conscious.

1.4.3 Glycaemic control during labour and birth

1.4.3.1 During labour and birth, capillary blood glucose should be monitored on an hourly basis in women with diabetes and maintained at between 4 and 7 mmol/litre.

1.4.3.2 Women with type 1 diabetes should be considered for intravenous dextrose and insulin infusion from the onset of established labour.

1.4.3.3 Intravenous dextrose and insulin infusion is recommended during labour and birth for women with diabetes whose blood glucose is not maintained at between 4 and 7 mmol/litre.

1.5  Neonatal care

1.5.1 Initial assessment and criteria for admission to intensive or special care

1.5.1.1 Women with diabetes should be advised to give birth in hospitals where advanced neonatal resuscitation skills are available 24 hours a day.

1.5.1.2 Babies of women with diabetes should be kept with their mothers unless there is a clinical complication or there are abnormal clinical signs that warrant admission for intensive or special care.

1.5.1.3 Blood glucose testing should be carried out routinely in babies of women with diabetes at 2–4 hours after birth. Blood tests for polycythaemia, hyperbilirubinemia, hypocalcaemia and hypomagnesaemia should be carried out for babies with
clinical signs.

1.5.1.4 Babies of women with diabetes should have an echocardiogram performed if they show clinical signs associated with congenital heart disease or cardiomyopathy, including heart murmur. The timing of the examination will depend on the clinical circumstances.

1.5.1.5 Babies of women with diabetes should be admitted to the neonatal unit if they have:

·      hypoglycaemia associated with abnormal clinical signs

·      respiratory distress

·      signs of cardiac decompensation due to congenital heart disease or cardiomyopathy

·      signs of neonatal encephalopathy

·      signs of polycythaemia and are likely to need partial
exchange transfusion

·      need for intravenous fluids

·      need for tube feeding (unless adequate support is available on the postnatal ward)

·      jaundice requiring intense phototherapy and frequent monitoring of bilirubinaemia

·      been born before 34 weeks (or between 34 and 36 weeks if dictated clinically by the initial assessment of the baby and feeding on the labour ward).

1.5.1.6 Babies of women with diabetes should not be transferred to community care until they are at least 24 hours old, and not before healthcare professionals are satisfied that the babies are maintaining blood glucose levels and are feeding well.

1.5.2 Prevention and assessment of neonatal hypoglycaemia

1.5.2.1  All maternity units should have a written policy for the prevention, detection and management of hypoglycaemia in babies of women with diabetes.

 1.5.2.2 Babies of women with diabetes should have their blood glucose tested using a quality-assured method validated for neonatal use (ward-based glucose electrode or laboratory analysis).

1.5.2.3 Babies of women with diabetes should feed as soon as possible after birth (within 30 minutes) and then at frequent intervals (every 2–3 hours) until feeding maintains pre-feed blood glucose levels at a minimum of 2.0 mmol/litre.

1.5.2.4 If blood glucose values are below 2.0 mmol/litre on two consecutive readings despite maximal support for feeding, if there are abnormal clinical signs or if the baby will not feed orally effectively, additional measures such as tube feeding or intravenous dextrose should be given. Additional measures should only be implemented if one or more of these criteria are met.

1.5.2.5 Babies of women with diabetes who present with clinical signs of hypoglycaemia should have their blood glucose tested and be treated with intravenous dextrose as soon as possible.

1.6     Postnatal care

This section should be read in conjunction with ‘Postnatal care: routine postnatal care of women and their babies’ (NICE clinical guideline 37). This guideline includes information on the care that all women and babies should receive in the first 6–8 weeks after birth (including information about breastfeeding).

1.6.1 Breastfeeding and effects on glycaemic control

1.6.1.1 Women with insulin-treated pre-existing diabetes should reduce their insulin immediately after birth and monitor their blood glucose levels carefully to establish the appropriate dose.

1.6.1.2 Women with insulin-treated pre-existing diabetes should be informed that they are at increased risk of hypoglycaemia in
the postnatal period, especially when breastfeeding, and they should be advised to have a meal or snack available before or during feeds.

1.6.1.3 Women who have been diagnosed with gestational diabetes should discontinue hypoglycaemic treatment immediately after birth.

1.6.1.4 Women with pre-existing type 2 diabetes who are breastfeeding can resume or continue to take metformin* and glibenclamide* immediately following birth but other oral hypoglycaemic agents should be avoided while breastfeeding.

1.6.1.5  Women with diabetes who are breastfeeding should continue to avoid any drugs for the treatment of diabetes complications that were discontinued for safety reasons in the pre-conception period.

1.6.2  Information and follow-up after birth

1.6.2.1 Women with pre-existing diabetes should be referred back to their routine diabetes care arrangements.

1.6.2.2 Women who were diagnosed with gestational diabetes should have their blood glucose tested to exclude persisting hyperglycaemia before they are transferred to community care.

1.6.2.3 Women who were diagnosed with gestational diabetes should be reminded of the symptoms of hyperglycaemia.

1.6.2.4 Women who were diagnosed with gestational diabetes should be offered lifestyle advice (including weight control, diet and exercise) and offered a fasting plasma glucose measurement (but not an OGTT) at the 6-week postnatal check and annually thereafter.

1.6.2.5Women who were diagnosed with gestational diabetes (including those with ongoing impaired glucose regulation) should be informed about the risks of gestational diabetes in future pregnancies and they should be offered screening (OGTT or fasting plasma glucose) for diabetes when planning future pregnancies.

1.6.2.6  Women who were diagnosed with gestational diabetes (including those with ongoing impaired glucose regulation) should be offered early self-monitoring of blood glucose or an OGTT in future pregnancies. A subsequent OGTT should be offered if the test results in early pregnancy are normal (see recommendation 1.2.2.4).

1.6.2.7 Women with diabetes should be reminded of the importance of contraception and the need for pre-conception care when planning future pregnancies.

2                                Notes on the scope of the guidance

NICE guidelines are developed in accordance with a scope that defines what the guideline will and will not cover.

How this guideline was developed

NICE commissioned the National Collaborating Centre for Women's and Children's Health to develop this guideline. The Centre established a Guideline Development Group (see appendix A), which reviewed the evidence and developed the recommendations. An independent Guideline Review Panel oversaw the development of the guideline (see appendix B).

3                                Implementation

The Healthcare Commission assesses the performance of NHS organisations in meeting core and developmental standards set by the Department of Health in ‘Standards for better health’. Implementation of clinical guidelines forms part of the developmental standard D2. Core standard C5 says that national agreed guidance should be taken into account when NHS organisations are planning and delivering care.

NICE has developed tools to help organisations implement this guidance (listed below).

·      Slides highlighting key messages for local discussion.

·      Costing tools:

-     costing report to estimate the national savings and costs associated with implementation

-     costing template to estimate the local costs and savings involved.

·      Implementation advice on how to put the guidance into practice and national initiatives that support this locally.

·      Audit support for monitoring local practice.

4                                Research recommendations

The Guideline Development Group has made the following recommendations for research, based on its review of evidence, to improve NICE guidance and the care of women with diabetes and their newborn babies in the future. The Guideline Development Group’s full set of research recommendations is detailed in the full guideline (see section 5).

4.1                         Screening, diagnosis and treatment for gestational diabetes

What is the clinical and cost effectiveness of the three main available screening techniques for gestational diabetes: risk factors, two-stage screening by the glucose challenge test and OGTT, and universal OGTT (with or without fasting)?

Why this is important

Following the Australian carbohydrate intolerance study in pregnant women (ACHOIS) it seems that systematic screening for gestational diabetes may be beneficial to the UK population. A multicentre randomized controlled trial is required to test the existing screening techniques, which have not been systematically evaluated for clinical and cost effectiveness (including acceptability) within the UK.

4.2                         Monitoring blood glucose and ketones during pregnancy

How effective is ambulatory continuous blood glucose monitoring in pregnancies complicated by diabetes?

Why this is important

The technology for performing ambulatory continuous blood glucose monitoring is only just becoming available, so there is currently no evidence to assess its effectiveness outside the laboratory situation. Research is needed to determine whether the technology is likely to have a place in the clinical management of diabetes in pregnancy. The new technology may identify women in whom short-term postprandial peaks of glycaemia are not detected by intermittent blood glucose testing. The aim of monitoring is to adjust insulin regimens to reduce the incidence of adverse outcomes of pregnancy (for example, fetal macrosomia, caesarean section and neonatal hypoglycaemia), so these outcomes should be assessed as part of the research.

4.3                         Management of diabetes during pregnancy

Do new-generation CSII pumps offer an advantage over traditional
intermittent insulin injections in terms of pregnancy outcomes in women with type 1 diabetes?

Why this is important

Randomized controlled trials have shown no advantage or disadvantage of using CSII pumps over intermittent insulin injections in pregnancy. A new generation of CSII pumps may offer technological advantages that would make a randomized controlled trial appropriate, particularly with the availability of insulin analogues (which may have improved the effectiveness of intermittent insulin injections).

4.4                         Monitoring fetal growth and well-being

How can the fetus at risk of intrauterine death be identified in women
with diabetes?

Why this is important

Unheralded intrauterine death remains a significant contributor to perinatal mortality in pregnancies complicated by diabetes. Conventional tests of fetal well-being (umbilical artery Doppler ultrasound, cardiotocography and other biophysical tests) have been shown to have poor sensitivity for predicting such events. Alternative approaches that include measurements of liquor erythropoietin and magnetic resonance imaging spectroscopy may be effective, but there is currently insufficient clinical evidence to evaluate
them. Well-designed randomized controlled trials that are sufficiently
powered are needed to determine whether these approaches are clinically and cost effective.

4.5                         Glycaemic control during labour and birth

What is the optimal method for controlling glycaemia during labour and birth?

Why this is important

Epidemiological studies have shown that poor glycaemic control during labour and birth is associated with adverse neonatal outcomes (in particular, neonatal hypoglycaemia and respiratory distress). However, no randomized controlled trials have compared the effectiveness of intermittent subcutaneous insulin injections and/or CSII with that of intravenous dextrose plus insulin during labour and birth. The potential benefits of intermittent insulin injections and/or CSII over intravenous dextrose plus insulin during the intrapartum period include patient preference due to the psychological effect of the woman feeling in control of her diabetes and having increased mobility. Randomized controlled trials are therefore needed to evaluate the safety of intermittent insulin injections and/or CSII during labour and birth compared with that of intravenous dextrose plus insulin.

5                                Other versions of this guideline

5.1                         Full guideline

The full guideline, 'Diabetes in pregnancy: management of diabetes and its complications from pre-conception to the postnatal period', contains details of the methods and evidence used to develop the guideline. It is published by the National Collaborating Centre for Women's and Children's Health.

5.2                         Quick reference guide

For printed copies, phone NICE publications on 0845 003 7783 or email publications@nice.org.uk (quote reference number N1484).

5.3                         Understanding NICE guidance

We encourage NHS and voluntary sector organisations to use text from this booklet in their own information about diabetes in pregnancy.

6                                Related NICE guidance

Published

Antenatal care: routine care for the healthy pregnant woman. NICE clinical guideline 62 (2008).

Intrapartum care: care of healthy women and their babies during childbirth. NICE clinical guideline 5 (2007).

Postnatal care: routine postnatal care of women and their babies. NICE clinical guideline 37 (2006).

Type 1 diabetes: diagnosis and management of type 1 diabetes in children, young people and adults. NICE clinical guideline 15 (2004).

Caesarean section. NICE clinical guideline 13 (2004).

Guidance on the use of patient-education models for diabetes. NICE technology appraisal guidance 60 (2003).

Guidance on the use of continuous subcutaneous insulin infusion for diabetes. NICE technology appraisal guidance 57 (2003).

Guidance on the use of glitazones for the treatment of type 2 diabetes. NICE technology appraisal guidance 63 (2003).

Guidance on the use of long-acting insulin analogues for the treatment of diabetes – insulin glargine. NICE technology appraisal guidance 53 (2002).

Improving the nutrition of pregnant and breastfeeding mothers and children in low-income households. NICE public health guidance 11 (2008).

Under development

NICE is developing the following guidance:

·      Type 2 diabetes: the management of type 2 diabetes. Update of NICE inherited clinical guidelines E, F, G, H and NICE technology appraisals 53, 60, 63 (publication expected April 2008).

·      Induction of labour. Update of NICE inherited clinical guideline D (publication expected June 2008).

·      Diabetes (type 2): newer agents for blood glucose control. NICE short clinical guideline (publication expected February 2009).

7                                Updating the guideline

NICE clinical guidelines are updated as needed so that recommendations take into account important new information. We check for new evidence 2 and 4 years after publication, to decide whether all or part of the guideline should be updated. If important new evidence is published at other times, we may decide to do a more rapid update of some recommendations.

Appendix A: The Guideline Development Group

Dominique Acolet (until October 2007)

Clinical Director (Perinatal Epidemiology), Confidential Enquiry into Maternal and Child Health (CEMACH), London

Lynne Carney

Development Officer, Fair Share Trust, Community Foundation for Shropshire and Telford (Lay Representative)

Anne Dornhorst

Consultant Physician and Honorary Senior Lecturer in Metabolic Medicine, Hammersmith Hospital, London

Robert Fraser

Reader in Obstetrics and Gynaecology, University of Sheffield

Roger Gadsby

General Practitioner, Nuneaton, and Senior Lecturer in Primary Care, University of Warwick

Jane Hawdon (from October 2007)

Consultant Neonatologist, University College Hospitals London NHS Foundation Trust

Richard Holt

Reader of Endocrinology and Metabolism, University of Southampton

Ann Parker

Diabetes Advisory Midwife, Royal Shrewsbury Hospital

Nickey Tomkins

Advanced Nurse Practitioner in Diabetes/Diabetes Specialist Midwife, Medway Primary Care Trust, Kent

Stephen Walkinshaw

Consultant in Maternal and Fetal Medicine, Liverpool Women’s Hospital

Jackie Webb

Diabetes Specialist Nurse Manager, Heart of England NHS Foundation Trust, Birmingham

Saiyyidah Zaidi

Programme Manager, Building Schools for the Future, London (Lay Representative)

NCC staff

Paula Broughton-Palmer

Senior Work Programme Coordinator

Michael Corkett

Senior Information Specialist

Anthony Danso-Appiah

Research Fellow

Paul Jacklin

Senior Health Economist

Lorelei Jones

Research Fellow, London School of Hygiene and Tropical Medicine (formerly Research Fellow, National Collaborating Centre for Women’s and Children’s Health)

Moira Mugglestone

Deputy Director

Jeffrey Round

Health Economist

Anuradha Sekhri

Research Fellow

Appendix B: The Guideline Review Panel

The Guideline Review Panel is an independent panel that oversees the development of the guideline and takes responsibility for monitoring adherence to NICE guideline development processes. In particular, the panel ensures that stakeholder comments have been adequately considered and responded to. The panel includes members from the following perspectives: primary care, secondary care, lay, public health and industry.

Professor Mike Drummond – Chair
Director, Centre for Health Economics, University of York

Dr Graham Archard
General Practitioner, Dorset

Ms Karen Cowley
Practice Development Nurse, York

Mr Barry Stables
Lay member

Dr David Gillen
Medical Director, Wyeth Pharmaceuticals

Ms Catherine Arkley
Lay member

* In this guideline, drug names are marked with an asterisk if they do not have UK marketing authorisation specifically for pregnant and breastfeeding women at the time of publication (March 2008). Informed consent should be obtained and documented.

 

Antenatal care:routine care for the healthy pregnant woman

 

NICE Clinical Guideline October 2003

Summary of recommendations and practice algorithm

3.2 Antenatal Education

Pregnant women should be offered opportunities to attend antenatal classes and have written information about antenatal care. [A]

Pregnant women should be offered evidence-based information and support to enable them to make informed decisions regarding their care. Information should include details of where they will be seen and who will undertake their care. Addressing women’s choices should be recognised as being integral to the decision-making process. [C]

At the first contact, pregnant women should be offered information about the pregnancy care services and options available, lifestyle considerations, including dietary information, and screening tests. [C]

 Pregnant women should be informed about the purpose of any screening test before it is performed. The right of a woman to accept or decline a test should be made clear. [D]

At each antenatal appointment, midwives and doctors should offer consistent information and clear explanations and should provide pregnant women with an opportunity to discuss issues and ask questions. [D]

 Communication and information should be provided in a form that is accessible to pregnant women who have additional needs, such as those with physical, cognitive or sensory disabilities and those who do not speak or read English. [Good practice point]

4.1 Who provides care?

Midwife- and GP-led models of care should be offered for women with an uncomplicated pregnancy. Routine involvement of obstetricians in the care of women with an uncomplicated pregnancy at scheduled times does not appear to improve perinatal outcomes compared with involving obstetricians when complications arise. [A]

4.2 Continuity of care

Antenatal care should be provided by a small group of carers with whom the woman feels comfortable. There should be continuity of care throughout the antenatal period. [A]

A system of clear referral paths should be established so that pregnant women who require additional care are managed and treated by the appropriate specialist teams when problems are identified. [D]

4.3 Where should antenatal appointments take place?

Antenatal care should be readily and easily accessible to all women and should be sensitive to the needs of individual women and the local community. [C]

4.4 Documentation of care

Structured maternity records should be used for antenatal care. [A]

Maternity services should have a system in place whereby women carry their own case notes. [A]

A standardised, national maternity record with an agreed minimum data set should be developed and used. This will help carers to provide the recommended evidence-based care to pregnant women. [Good practice point]

4.5 Frequency of antenatal appointments

A schedule of antenatal appointments should be determined by the function of the appointments.

For a woman who is nulliparous with an uncomplicated pregnancy, a schedule of ten appointments should be adequate. For a woman who is parous with an uncomplicated pregnancy, a schedule of seven appointments should be adequate. [B]

Early in pregnancy, all women should receive appropriate written information about the likely number, timing and content of antenatal appointments associated with different options of care and be given an opportunity to discuss this schedule with their midwife or doctor. [D]

Each antenatal appointment should be structured and have focused content. Longer appointments are needed early in pregnancy to allow comprehensive assessment and discussion. Wherever possible, appointments should incorporate routine tests and investigations to minimise inconvenience to women. [D]

4.6 Gestational age assessment: LMP and ultrasound

Pregnant women should be offered an early ultrasound scan to determine gestational age (in lieu of last menstrual period (LMP) for all cases) and to detect multiple pregnancies. This will ensure consistency of gestational age assessments, improve the performance of mid-trimester serum screening for Down’s syndrome and reduce the need for induction of labour after 41 weeks. [A] Ideally, scans should be performed between 10 and 13 weeks and use crown–rump length measurement to determine gestational age.

Pregnant women who present at or beyond 14 weeks of gestation should be offered an ultrasound scan to estimate gestational age using head circumference or biparietal diameter. [Good practice point]

4.7 What should happen at antenatal appointments?

First appointment

The first appointment needs to be earlier in pregnancy (prior to 12 weeks) than may have traditionally occurred and, because of the large volume of information needs in early pregnancy, two appointments may be required. At the first (and second) antenatal appointment:

• give information, with an opportunity to discuss issues and ask questions; offer verbal information supported by written information (on topics such as diet and lifestyle considerations, pregnancy care services available, maternity benefits and sufficient information to enable informed decision making about screening tests)

• identify women who may need additional care and plan pattern of care for the pregnancy

• check blood group and rhesus D (RhD) status

• offer screening for anaemia, red-cell alloantibodies, Hepatitis B virus, HIV, rubella susceptibility and syphilis

• offer screening for asymptomatic bacteriuria (ASB)

• offering screening for Down’s syndrome • offer early ultrasound scan for gestational age assessment

• offer ultrasound screening for structural anomalies (20 weeks)

• measure BMI and blood pressure (BP) and test urine for proteinuria .

After the first (and possibly second) appointment, for women who choose to have screening, the following test should be arranged before 16 weeks of gestation (except serum screening for Down’s syndrome, which may occur up to 20 weeks of gestation):

• blood tests (for checking blood group and RhD status and screening for anaemia, red-cell alloantibodies, hepatitis B virus, HIV, rubella susceptibility and syphilis)

 • urine tests (to check for proteinuria and screen for ASB)

• ultrasound scan to determine gestational age using:

• crown–rump measurement if performed at 10 to 13 weeks

• biparietal diameter or head circumference at or beyond 14 weeks

• Down’s syndrome screening using:

• nuchal translucency at 11 to 14 weeks

• serum screening at 14 to 20 weeks.

16 weeks

The next appointment should be scheduled at 16 weeks to:

• review, discuss and record the results of all screening tests undertaken; reassess planned pattern of care for the pregnancy and identify women who need additional care

 • investigate a haemoglobin level of less than 11g/dl and consider iron supplementation if indicated

• measure BP and test urine for proteinuria

• give information, with an opportunity to discuss issues and ask questions; offer verbal information supported by antenatal classes and written information.

18–20 weeks

At 18–20 weeks, if the woman chooses, an ultrasound scan should be performed for the detection of structural anomalies.

For a woman whose placenta is found to extend across the internal cervical os at this time, another scan at 36 weeks should be offered and the results of this scan reviewed at the 36-week appointment.

25 weeks

 At 25 weeks of gestation, another appointment should be scheduled for nulliparous women.

 At this appointment:

• measure and plot symphysis–fundal height

• measure BP and test urine for proteinuria

• give information, with an opportunity to discuss issues and ask questions; offer verbal information supported by antenatal classes and written information.

28 weeks

The next appointment for all pregnant women should occur at 28 weeks.

At this appointment:

• offer a second screening for anaemia and atypical red-cell alloantibodies

• investigate a haemoglobin level of less than 10.5 g/dl and consider iron supplementation, if indicated

 • offer anti-D to rhesus-negative women

• measure BP and test urine for proteinuria

• measure and plot symphysis–fundal height

• give information, with an opportunity to discuss issues and ask questions; offer verbal information supported by antenatal classes and written information.

31 weeks

 Nulliparous women should have an appointment scheduled at 31 weeks to:

• measure BP and test urine for proteinuria

• measure and plot symphysis–fundal height

• review, discuss and record the results of screening tests undertaken at 28 weeks; reassess planned pattern of care for the pregnancy and identify women who need additional care

5.6 Food-acquired infections

Pregnant women should be offered information on how to reduce the risk of listeriosis by:

• drinking only pasteurised or UHT milk

• not eating ripened soft cheese such as Camembert, Brie and blue-veined cheese (there is no risk with hard cheeses, such as Cheddar, or cottage cheese and processed cheese)

 • not eating pâté (of any sort, including vegetable)

• not eating uncooked or undercooked ready-prepared meals. [D] Pregnant women should be offered information on how to reduce the risk of salmonella infection by:

 • avoiding raw or partially cooked eggs or food that may contain them (such as mayonnaise)

 • avoiding raw or partially cooked meat, especially poultry. [D]

5.7 Prescribed medicines

Few medicines have been established as safe to use in pregnancy. Prescription medicines should be used as little as possible during pregnancy and should be limited to circumstances where the benefit outweighs the risk. [D]

5.8 Over-the-counter medicines

Pregnant women should be informed that few over-the-counter (OTC) medicines have been established as being safe to take in pregnancy. OTC medicines should be used as little as possible during pregnancy. [D]

5.9 Complementary therapies

Pregnant women should be informed that few complementary therapies have been established as being safe and effective during pregnancy. Women should not assume that such therapies are safe and they should be used as little as possible during pregnancy. [D]

5.10 Exercise in pregnancy

Pregnant women should be informed that beginning or continuing a moderate course of exercise during pregnancy is not associated with adverse outcomes. [A] Pregnant women should be informed of the potential dangers of certain activities during pregnancy, for example, contact sports, high-impact sports and vigorous racquet sports that may involve the risk of abdominal trauma, falls or excessive joint stress, and scuba diving, which may result in fetal birth defects and fetal decompression disease. [D]

5.11 Sexual intercourse in pregnancy

Pregnant woman should be informed that sexual intercourse in pregnancy is not known to be associated with any adverse outcomes. [B]

5.12 Alcohol and smoking in pregnancy

Excess alcohol has an adverse effect on the fetus. Therefore it is suggested that women limit alcohol consumption to no more than one standard unit per day. Each of the following constitutes one ‘unit’ of alcohol: a single measure of spirits, one small glass of wine, and a half pint of ordinary strength beer, lager or cider. [C]

Pregnant women should be informed about the specific risks of smoking during pregnancy (such as the risk of having a baby with low birthweight and preterm). The benefits of quitting at any stage should be emphasised. [A]

Women who smoke or who have recently stopped should be offered smoking cessation interventions. Interventions that appear to be effective in reducing smoking include advice by physician, group sessions and behavioural therapy (based on self-help manuals). [A] Women who are unable to quit smoking during pregnancy should be encouraged to reduce smoking. [B]

5.13 Cannabis use in pregnancy

The direct effects of cannabis on the fetus are uncertain but may be harmful. Cannabis use is associated with smoking, which is known to be harmful; therefore women should be discouraged from using cannabis during pregnancy. [C]

5.14 Air travel during pregnancy

 Pregnant women should be informed that long-haul air travel is associated with an increased risk of venous thrombosis, although whether or not there is additional risk during pregnancy is unclear. In the general population, wearing correctly fitted compression stockings is effective at reducing the risk. [B]

5.15 Car travel during pregnancy

Pregnant women should be informed about the correct use of seatbelts (that is, three-point seatbelts “above and below the bump, not over it”). [B]

5.16 Travelling abroad during pregnancy

Pregnant women should be informed that, if they are planning to travel abroad, they should discuss considerations such as flying, vaccinations and travel insurance with their midwife or doctor. [Good practice point]

Management of common symptoms of pregnancy

6.1 Nausea and vomiting in early pregnancy

Women should be informed that most cases of nausea and vomiting in pregnancy will resolve spontaneously within 16 to 20 weeks of gestation and that nausea and vomiting are not usually associated with a poor pregnancy outcome. If a woman requests or would like to consider treatment, the following interventions appear to be effective in reducing symptoms [A]:

• nonpharmacological:

 • ginger

• P6 acupressure

• pharmacological:

 • antihistamines.

Information about all forms of self-help and nonpharmacological treatments should be made available for pregnant women who have nausea and vomiting. [Good practice point]

 6.2 Heartburn

Women who present with symptoms of heartburn in pregnancy should be offered information regarding lifestyle and diet modification. [Good practice point] Antacids may be offered to women whose heartburn remains troublesome despite lifestyle and diet modification. [A]

6.3 Constipation

 Women who present with constipation in pregnancy should be offered information regarding diet modification, such as bran or wheat fibre supplementation. [A]

6.4 Haemorrhoids

 In the absence of evidence of the effectiveness of treatments for haemorrhoids in pregnancy, women should be offered information concerning diet modification. If clinical symptoms remain troublesome, standard haemorrhoid creams should be considered. [Good practice point]

6.5 Varicose veins

Women should be informed that varicose veins are a common symptom of pregnancy that will not cause harm and that compression stockings can improve the symptoms but will not prevent varicose veins from emerging. [A]

6.6 Vaginal discharge

Women should be informed that an increase in vaginal discharge is a common physiological change that occurs during pregnancy. If this is associated with itch, soreness, offensive smell or pain on passing urine there maybe an infective cause and investigation should be considered. [Good practice point] A 1-week course of a topical imidazole is an effective treatment and should be considered for vaginal candidiasis infections in pregnant women. [A] The effectiveness and safety of oral treatments for vaginal candidiasis in pregnancy is uncertain and these should not be offered. [Good practice point]

6.7 Backache

Women should be informed that exercising in water, massage therapy and group or individual back care classes might help to ease backache during pregnancy. [A]

Clinical examination of pregnant women

7.1 Measurement of weight and body mass index

Maternal weight and height should be measured at the first antenatal appointment, and the woman’s body mass index (BMI) calculated (weight [kg]/height[m]2). [B]

Repeated weighing during pregnancy should be confined to circumstances where clinical management is likely to be influenced. [C]

7.2 Breast examination

Routine breast examination during antenatal care is not recommended for the promotion of postnatal breastfeeding. [A]

7.3 Pelvic examination

Routine antenatal pelvic examination does not accurately assess gestational age, nor does it accurately predict preterm birth or cephalopelvic disproportion. It is not recommended. [B]

7.4 Female genital mutilation

Pregnant women who have had female genital mutilation should be identified early in antenatal care through sensitive enquiry. Antenatal examination will then allow planning of intrapartum care. [C]

7.5 Domestic violence

Health care professionals need to be alert to the symptoms or signs of domestic violence and women should be given the opportunity to disclose domestic violence in an environment in which they feel secure. [D]

 7.6 Psychiatric screening

Women should be asked early in pregnancy if they have had any previous psychiatric illnesses. Women who have had a past history of serious psychiatric disorder should be referred for a psychiatric assessment during the antenatal period. [B]

Pregnant women should not be offered routine screening, such as with the Edinburgh Postnatal Depression Scale, in the antenatal period to predict the development of postnatal depression. [A]

Pregnant women should not be offered antenatal education interventions to reduce perinatal or postnatal depression, as these interventions have not been shown to be effective. [A]

Screening for haematological conditions

8.1 Anaemia

Pregnant women should be offered screening for anaemia. Screening should take place early in pregnancy (at the first appointment) and at 28 weeks when other blood screening tests are being performed. This allows enough time for treatment if anaemia is detected. [B]

Haemoglobin levels outside the normal UK range for pregnancy (that is, 11 g/dl at first contact and 10.5 g/dl at 28 weeks) should be investigated and iron supplementation considered if indicated. [A]

8.3 Blood grouping and red cell alloantibodies

Women should be offered testing for blood group and RhD status in early pregnancy. [B]

It is recommended that routine antenatal anti-D prophylaxis is offered to all non-sensitised pregnant women who are RhD negative. [NICE 2002] Women should be screened for atypical red cell alloantibodies in early pregnancy and again at 28 weeks regardless of their RhD status. [B]

 Pregnant women with clinically significant atypical red cell alloantibodies should be offered referral to a specialist centre for further investigation and advice on subsequent antenatal management.[D]

If a pregnant woman is RhD-negative, consideration should be given to offering partner testing to determine whether the administration of anti-D prophylaxis is necessary. [Good practice point]

Screening for fetal anomalies

9.1 Screening for structural anomalies

Pregnant women should be offered an ultrasound scan to screen for structural anomalies, ideally between 18 and 20 weeks of gestation, by an appropriately trained sonographer and with equipment of an appropriate standard [A]

9.2 Screening for Down’s syndrome Pregnant women should be offered screening for Down’s syndrome with a test that provides the current standard of a detection rate above 60% and a false positive rate of less than 5%.

The following tests meet this standard:

• From 11 to 14 weeks:

• nuchal translucency (NT)

• the combined test (NT, hCG and PAPP-A)

• From 14 to 20 weeks:

• the triple test (hCG, AFP and uE3)

 • the quadruple test (hCG, AFP, uE3, inhibin A)

• From 11 to 14 weeks AND 14 to 20 weeks:

• the integrated test (NT, PAPP-A + hCG, AFP, uE3, inhibin A)

 • the serum integrated test (PAPP-A + hCG, AFP, uE3, inhibin A). [B]

Pregnant women should be offered screening for Down’s syndrome with a test which provides a detection rate above 75% and a false positive rate of less than 3%. These performance measures should be age standardised and based on a cutoff of 1/250 at term. The following tests currently meet this standard:

 • From 11 to 14 weeks:

• the combined test (NT, hCG and PAPP-A)

• From 14 to 20 weeks:

 • the quadruple test (hCG, AFP, uE3, inhibin A)

 • From 11 to 14 weeks AND 14 to 20 weeks:

• the integrated test (NT, PAPP-A + hCG, AFP, uE3, inhibin A)

• the serum integrated test (PAPP-A + hCG, AFP, uE3, inhibin A). [B]

Pregnant women should be given information about the detection rates and false positive rates of any Down’s syndrome screening test being offered and about further diagnostic tests that may be offered. The woman’s right to accept or decline the test should be made clear. [D]

Screening for infections

10.1 Asymptomatic bacteriuria

Pregnant women should be offered routine screening for asymptomatic bacteriuria by midstream urine culture early in pregnancy. Identification and treatment of asymptomatic bacteriuria reduces the risk of preterm birth. [A]

10.2 Asymptomatic bacterial vaginosis

 Pregnant women should not be offered routine screening for bacterial vaginosis because the evidence suggests that the identification and treatment of asymptomatic bacterial vaginosis does not lower the risk for preterm birth and other adverse reproductive outcomes. [A]

 10.3 Chlamydia trachomatis

Pregnant women should not be offered routine screening for asymptomatic chlamydia because there is insufficient evidence on its effectiveness and cost effectiveness. However, this policy is likely to change with the implementation of the national opportunistic chlamydia screening programme. [C]

10.4 Cytomegalovirus

The available evidence does not support routine cytomegalovirus screening in pregnant women and it should not be offered. [B]

10.5 Hepatitis B virus

Serological screening for hepatitis B virus should be offered to pregnant women so that effective postnatal intervention can be offered to infected women to decrease the risk of mother-to-child transmission. [A]

10.6 Hepatitis C virus

Pregnant women should not be offered routine screening for hepatitis C virus because there is insufficient evidence on its effectiveness and cost effectiveness. [C]

10.7 HIV

Pregnant women should be offered screening for HIV infection early in antenatal care because appropriate antenatal interventions can reduce mother-to-child transmission of HIV infection. [A]

 A system of clear referral paths should be established in each unit or department so that pregnant women who are diagnosed with an HIV infection are managed and treated by the appropriate specialist teams. [D]

10.8 Rubella

Rubella susceptibility screening should be offered early in antenatal care to identify women at risk of contracting rubella infection and to enable vaccination in the postnatal period for the protection of future pregnancies. [B]

10.9 Streptococcus

Group B Pregnant women should not be offered routine antenatal screening for group B streptococcus (GBS) because evidence of its clinical effectiveness and cost effectiveness remains uncertain. [C]

10.10 Syphilis

Screening for syphilis should be offered to all pregnant women at an early stage in antenatal care because treatment of syphilis is beneficial to the mother and fetus. [B]

Because syphilis is a rare condition in the UK and a positive result does not necessarily mean that a woman has syphilis, clear paths of referral for the management of women testing positive for syphilis should be established. [Good practice point]

10.11 Toxoplasmosis

 Routine antenatal serological screening for toxoplasmosis should not be offered because the harms of screening may outweigh the potential benefits. [B] Pregnant women should be informed of primary prevention measures to avoid toxoplasmosis infection such as:

• washing hands before handling food

• thoroughly washing all fruit and vegetables, including ready-prepared salads, before eating

• thoroughly cooking raw meats and ready-prepared chilled meals

• wearing gloves and thoroughly washing hands after handling soil and gardening

• avoiding cat faeces in cat litter or in soil. [C]

Screening for clinical conditions

11.1 Gestational diabetes mellitus

 The evidence does not support routine screening for gestational diabetes mellitus (GDM) and therefore it should not be offered. [B]

11.2 Pre-eclampsia

At first contact a woman’s level of risk for pre-eclampsia should be evaluated so that a plan for her subsequent schedule of antenatal appointments can be formulated. The likelihood of developing pre-eclampsia during a pregnancy is increased in women who:

 • are nulliparous

 • are age 40 or older

• have a family history of pre-eclampsia (e.g., pre-eclampsia in a mother or sister)

• have a prior history of pre-eclampsia

• have a body mass index (BMI) at or above 35 at first contact

• have a multiple pregnancy or pre-existing vascular disease (for example, hypertension or diabetes). [C]

Whenever blood pressure is measured in pregnancy, a urine sample should be tested at the same time for proteinuria. [C]

Standardised equipment, techniques and conditions for blood-pressure measurement should be used by all personnel whenever blood pressure is measured in the antenatal period so that valid comparisons can be made. [C]

Pregnant women should be informed of the symptoms of advanced pre-eclampsia because these may be associated with poorer pregnancy outcomes for the mother or baby. Symptoms include headache, problems with vision, such as blurring or flashing before the eyes, bad pain just below the ribs, vomiting and sudden swelling of face, hands or feet. [D]

 11.3 Preterm birth

Routine vaginal examination to assess the cervix is not an effective method of predicting preterm birth and should not be offered. [A]

Although cervical shortening identified by transvaginal ultrasound examination and increased levels of fetal fibronectin are associated with an increased risk for preterm birth, the evidence does not indicate that this information improves outcomes; therefore, neither routine antenatal cervical assessment by transvaginal ultrasound nor the measurement of fetal fibronectin should be used to predict preterm birth in healthy pregnant women. [B]

11.4 Placenta praevia

Because most low-lying placentas detected at a 20-week anomaly scan will resolve by the time the baby is born, only a woman whose placenta extends over the internal cervical os should be offered another transabdominal scan at 36 weeks. If the transabdominal scan is unclear, a transvaginal scan should be offered. [C]

Fetal growth and wellbeing

12.1 Abdominal palpation for fetal presentation

 Fetal presentation should be assessed by abdominal palpation at 36 weeks or later, when presentation is likely to influence the plans for the birth. Routine assessment of presentation by abdominal palpation should not be offered before 36 weeks because it is not always accurate and may be uncomfortable. [C]

Suspected fetal malpresentation should be confirmed by an ultrasound assessment. [Good practice point]

12.2 Measurem ent of symphysis–fundal distance

Pregnant women should be offered estimation of fetal size at each antenatal appointment to detect small- or large-for-gestational-age infants. [A] Symphysis–fundal height should be measured and plotted at each antenatal appointment. [Good practice point]

12.3 Routine monitoring of fetal movements

Routine formal fetal-movement counting should not be offered. [A]

12.4 Auscultation of fetal heart

Auscultation of the fetal heart may confirm that the fetus is alive but is unlikely to have any predictive value and routine listening is therefore not recommended. However, when requested by the mother, auscultation of the fetal heart may provide reassurance. [D]

 12.5 Cardiotocography

The evidence does not support the routine use of antenatal electronic fetal heart rate monitoring (cardiotocography) for fetal assessment in women with an uncomplicated pregnancy and therefore it should not be offered. [A]

12.6 Ultrasound assessment in the third trimester

The evidence does not support the routine use of ultrasound scanning after 24 weeks of gestation and therefore it should not be offered. [A]

12.7 Umbilical and uterine artery Doppler ultrasound

The use of umbilical artery Doppler ultrasound for the prediction of fetal growth restriction should not be offered routinely. [A]

The use of uterine artery Doppler ultrasound for the prediction of pre-eclampsia should not be offered routinely. [B]

Management of specific clinical conditions

13.1 Pregnancy after 41 weeks

Prior to formal induction of labour, women should be offered a vaginal examination for membrane sweeping. [A]

Women with uncomplicated pregnancies should be offered induction of labour beyond 41 weeks. [A]

From 42 weeks, women who decline induction of labour should be offered increased antenatal monitoring consisting of at least twice-weekly cardiotocography and ultrasound estimation of maximum amniotic pool depth. [Good practice point]

13.2 Breech presentation at term

All women who have an uncomplicated singleton breech pregnancy at 36 weeks of gestation should be offered external cephalic version (ECV). Exceptions include women in labour and women with a uterine scar or abnormality, fetal compromise, ruptured membranes, vaginal bleeding and medical conditions. [A]

 Where it is not possible to schedule an appointment for ECV at 37 weeks of gestation, it should be scheduled at 36 weeks. [Good practice point]

 

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