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 BEST PRACTICE GUIDELINES

 

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