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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.
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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 |
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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 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
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]
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Nice Guidelines for 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
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© National Institute for Health and
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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,
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.
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 | |