DRAFT FOR CONSULTATION
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2 Preterm labour and birth
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5 NICE guideline: short version
6 Draft for consultation, June 2015
7 If you wish to comment on this version of the guideline, please be aware that all the supporting information and evidence is contained in the full version.
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1 Contents
2 Introduction ...... 3 3 Patient-centred care ...... 5 4 Strength of recommendations ...... 6 5 1 Recommendations ...... 8 6 Terms used in this guideline ...... 8 7 1.1 Information and support ...... 9 8 1.2 Prophylactic vaginal progesterone and prophylactic cervical cerclage 9 10 10 1.3 Diagnosing preterm prelabour rupture of membranes (P-PROM) ..... 11 11 1.4 Antenatal prophylactic antibiotics for women with P-PROM ...... 12 12 1.5 Identifying infection in women with P-PROM ...... 12 13 1.6 'Rescue’ cervical cerclage ...... 13 14 1.7 Diagnosing preterm labour for women with intact membranes ...... 13 15 1.8 Maternal corticosteroids ...... 16 16 1.9 Magnesium sulfate for neuroprotection ...... 16 17 1.10 Tocolysis...... 17 18 1.11 Fetal monitoring ...... 18 19 1.12 Mode of birth ...... 20 20 1.13 Timing of cord clamping for preterm babies (born vaginally or by 21 caesarean section) ...... 21 22 2 Implementation: getting started ...... 22 23 3 Research recommendations ...... 22 24 4 Other information ...... 25 25 5 The Guideline Committee, National Collaborating Centre and NICE 26 project team, and declarations of interests ...... 28
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1 Introduction
2 Preterm birth is the single biggest cause of neonatal mortality and morbidity in 3 the UK. Over 52,000 babies (around 7.3% of live births) in England and Wales 4 in 2012 were born preterm – that is, before 37+0 weeks of pregnancy. There 5 has been no decline in the preterm birth rate in the UK over the last 10 years.
6 Babies born preterm have high rates of early, late and postneonatal mortality, 7 and the risk of mortality increases as gestational age at birth decreases. 8 Babies who survive have increased rates of disability. Recent UK studies 9 comparing cohorts born in 1995 and 2006 have shown improved rates of 10 survival (from 40% to 53%) for extreme preterm births (born between 22 and 11 26 weeks). Rates of disability among survivors were largely unchanged over 12 this time period.
13 The major long-term consequence of prematurity is neurodevelopmental 14 disability. Although the risk for the individual child is greatest for those born at 15 the earliest gestational ages, the global burden of neurodevelopmental 16 disabilities depends on the number of babies born at each of these gestations, 17 and so is greatest for babies born between 32 and 36 weeks, less for those 18 born between 28 and 31 weeks, and least for those born at less than 19 28 weeks gestation.
20 Around 75% of women delivering preterm do so after preterm labour, which 21 may or may not be preceded by preterm prelabour rupture of membranes. 22 The remaining women delivering preterm have an elective preterm birth when 23 this is thought to be in the fetal or maternal interest (for example, because of 24 extreme growth retardation in the baby or maternal conditions such as pre- 25 eclampsia).
26 This guideline reviews the evidence for the best way to provide treatment for 27 women who present with symptoms and signs of preterm labour and women 28 who are scheduled to have a preterm birth. It also reviews how preterm birth 29 can be optimally diagnosed in symptomatic women, given that many women 30 thought to be in preterm labour on a clinical assessment will not deliver 31 preterm.
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1 The guideline does not cover who should and should not have medically 2 indicated preterm birth, or diagnostic or predictive tests in asymptomatic 3 women.
4 Medicines
5 The guideline will assume that prescribers will use a medicine’s summary of 6 product characteristics to inform decisions made with individual patients.
7 This guideline recommends some medicines for indications for which they do 8 not have a UK marketing authorisation at the date of publication, if there is 9 good evidence to support that use. The prescriber should follow relevant 10 professional guidance, taking full responsibility for the decision. The patient 11 (or those with authority to give consent on their behalf) should provide 12 informed consent, which should be documented. See the General Medical 13 Council’s Prescribing guidance: prescribing unlicensed medicines for further 14 information. Where recommendations have been made for the use of 15 medicines outside their licensed indications (‘off-label use’), these medicines 16 are marked with a footnote in the recommendations.
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1 Patient-centred care
2 This guideline offers best practice advice on the care of women during 3 preterm labour and birth.
4 Patients and healthcare professionals have rights and responsibilities as set 5 out in the NHS Constitution for England – all NICE guidance is written to 6 reflect these. Treatment and care should take into account individual needs 7 and preferences. Patients should have the opportunity to make informed 8 decisions about their care and treatment, in partnership with their healthcare 9 professionals. If the patient is under 16, their family or carers should also be 10 given information and support to help the child or young person to make 11 decisions about their treatment. If it is clear that the child or young person fully 12 understands the treatment and does not want their family or carers to be 13 involved, they can give their own consent. Healthcare professionals should 14 follow the Department of Health’s advice on consent. If someone does not 15 have capacity to make decisions, healthcare professionals should follow the 16 code of practice that accompanies the Mental Capacity Act and the 17 supplementary code of practice on deprivation of liberty safeguards.
18 NICE has produced guidance on the components of good patient experience 19 in adult NHS services. All healthcare professionals should follow the 20 recommendations in Patient experience in adult NHS services..
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1 Strength of recommendations
2 Some recommendations can be made with more certainty than others. The 3 Guideline Committee makes a recommendation based on the trade-off 4 between the benefits and harms of an intervention, taking into account the 5 quality of the underpinning evidence. For some interventions, the Guideline 6 Committee is confident that, given the information it has looked at, most 7 patients would choose the intervention. The wording used in the 8 recommendations in this guideline denotes the certainty with which the 9 recommendation is made (the strength of the recommendation).
10 For all recommendations, NICE expects that there is discussion with the 11 patient about the risks and benefits of the interventions, and their values and 12 preferences. This discussion aims to help them to reach a fully informed 13 decision (see also ‘Patient-centred care’).
14 Interventions that must (or must not) be used
15 We usually use ‘must’ or ‘must not’ only if there is a legal duty to apply the 16 recommendation. Occasionally we use ‘must’ (or ‘must not’) if the 17 consequences of not following the recommendation could be extremely 18 serious or potentially life threatening.
19 Interventions that should (or should not) be used – a ‘strong’ 20 recommendation
21 We use ‘offer’ (and similar words such as ‘refer’ or ‘advise’) when we are 22 confident that, for the vast majority of patients, an intervention will do more 23 good than harm, and be cost effective. We use similar forms of words (for 24 example, ‘Do not offer…’) when we are confident that an intervention will not 25 be of benefit for most patients.
26 Interventions that could be used
27 We use ‘consider’ when we are confident that an intervention will do more 28 good than harm for most patients, and be cost effective, but other options may 29 be similarly cost effective. The choice of intervention, and whether or not to 30 have the intervention at all, is more likely to depend on the patient’s values
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1 and preferences than for a strong recommendation, and so the healthcare 2 professional should spend more time considering and discussing the options 3 with the patient.
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1
2 1 Recommendations
3 The following guidance is based on the best available evidence. The full 4 guideline [hyperlink to be added for final publication] gives details of the 5 methods and the evidence used to develop the guidance.
6 Terms used in this guideline
7 Symptoms of preterm labour 8 A woman has presented before 37+0 weeks of pregnancy reporting symptoms 9 that might be indicative of preterm labour (such as abdominal pain), but no 10 clinical assessment (including speculum or digital vaginal examination) has 11 taken place.
12 Suspected preterm labour 13 A woman is in suspected preterm labour if she has reported symptoms of 14 preterm labour and has had a clinical assessment (including a speculum or 15 digital vaginal examination) that confirms the possibility of preterm labour but 16 rules out established labour.
17 Diagnosed preterm labour 18 A woman is in diagnosed preterm labour if she is in suspected preterm labour 19 and has had a positive diagnostic test for preterm labour.
20 Established preterm labour 21 A woman is in established preterm labour if she has progressive cervical 22 dilatation from 4 cm with regular contractions (see recommendation 1.3.1 in 23 the NICE guideline on intrapartum care).
24 Preterm prelabour rupture of membranes (P-PROM) 25 A woman is described as having P-PROM if she has ruptured membranes 26 before 37+0 weeks of pregnancy but is not in established labour.
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1 'Rescue' cervical cerclage 2 Cervical cerclage performed as an emergency procedure in a woman with
3 premature cervical dilatation and often with exposed fetal membranes.
4 1.1 Information and support
5 1.1.1 When giving information and support to women at increased risk of 6 preterm labour, with suspected, diagnosed or established preterm 7 labour, or having a planned preterm birth (and their family members 8 or carers as appropriate):
9 give this information and support as early as possible, taking into 10 account the likelihood of preterm birth and the status of labour 11 follow the principles in the NICE guideline on patient experience 12 in adult NHS services 13 give both oral and written information 14 describe the symptoms and signs of preterm labour 15 explain to the woman about the care she might be offered.
16 1.1.2 For women who are having a planned preterm birth or are offered 17 treatment for preterm labour in line with sections 1.8–1.10 (and 18 their family members or carers as appropriate), provide information 19 and support that includes:
20 information about the likelihood of the baby surviving and other 21 outcomes (including long-term outcomes) and risks for the baby, 22 giving values as natural frequencies (for example, 1 in 100) 23 explaining about the neonatal care of preterm babies, including 24 location of care 25 explaining about the immediate problems that can arise when a 26 baby is born preterm 27 explaining about the possible long-term consequences of 28 prematurity for the baby (how premature babies grow and 29 develop)
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1 ongoing opportunities to talk about and state their wishes about 2 resuscitation of the baby 3 an opportunity to tour the neonatal unit 4 an opportunity to speak to a neonatologist or paediatrician.
5 1.2 Prophylactic vaginal progesterone and prophylactic 6 cervical cerclage
7 1.2.1 Offer a choice of either prophylactic vaginal progesterone or 8 prophylactic cervical cerclage to women:
9 with a history of spontaneous preterm birth or mid-trimester loss 10 between 16+0 and 34+0 weeks of pregnancy and 11 in whom a transvaginal ultrasound scan has been carried out 12 between 16+0 and 24+0 weeks of pregnancy that reveals a 13 cervical length of less than 25 mm.
14 Discuss the benefits and risks of prophylactic progesterone and 15 cervical cerclage with the woman and take her preferences into 16 account.
17 1.2.2 Offer prophylactic vaginal progesterone to women with no history of 18 spontaneous preterm birth or mid-trimester loss in whom a 19 transvaginal ultrasound scan has been carried out between 16+0 20 and 24+0 weeks of pregnancy that reveals a cervical length of less 21 than 25 mm.
22 1.2.3 Consider prophylactic cervical cerclage for women in whom a 23 transvaginal ultrasound scan has been carried out between 16+0 24 and 24+0 weeks of pregnancy that reveals a cervical length of less 25 than 25 mm and who have either:
26 had preterm prelabour rupture of membranes (P-PROM) in a 27 previous pregnancy or 28 a history of cervical trauma.
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1 1.3 Diagnosing preterm prelabour rupture of membranes 2 (P-PROM)
3 1.3.1 In a woman reporting symptoms suggestive of preterm prelabour 4 rupture of membranes (P-PROM), offer a speculum examination to 5 look for pooling of amniotic fluid and:
6 if pooling of amniotic fluid is observed, do not perform any 7 diagnostic test but offer care consistent with the woman having 8 P-PROM (see sections 1.4, 1.5 and 1.8) 9 if pooling of amniotic fluid is not observed, consider performing 10 an insulin-like growth factor binding protein-1 test or placental 11 alpha-microglobulin-1 test of vaginal fluid.
12 1.3.2 If the results of the insulin-like growth factor binding protein-1 or 13 placental alpha-microglobulin-1 test are positive, do not use the test 14 results alone to decide what care to offer the woman, but also take 15 into account her clinical condition, her medical and pregnancy 16 history and gestational age, and either:
17 offer care consistent with the woman having P-PROM (see 18 sections 1.4, 1.5 and 1.8) or 19 re-evaluate the woman’s diagnostic status at a later time point.
20 1.3.3 If the results of the insulin-like growth factor binding protein-1 or 21 placental alpha-microglobulin-1 test are negative and no amniotic 22 fluid is observed:
23 do not offer antenatal prophylactic antibiotics 24 explain to the woman that it is unlikely that she has P-PROM, 25 but that she should return if she has any further symptoms 26 suggestive of P-PROM or preterm labour.
27 1.3.4 Do not use nitrazine to diagnose P-PROM.
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1 1.3.5 Do not perform diagnostic tests for P-PROM if labour becomes 2 established in a woman reporting symptoms suggestive of P- 3 PROM.
4 1.4 Antenatal prophylactic antibiotics for women with P- 5 PROM
6 1.4.1 Offer women with P-PROM oral erythromycin 250 mg 4 times a 7 day1 for a maximum of 10 days or until the woman is in established 8 labour (whichever is sooner).
9 1.4.2 For women with P-PROM who cannot tolerate erythromycin or in 10 whom erythromycin is contraindicated, consider oral penicillin for a 11 maximum of 10 days or until the woman is in established labour 12 (whichever is sooner).
13 1.4.3 Do not offer women with P-PROM co-amoxiclav as prophylaxis for 14 intrauterine infection.
15 1.4.4 For guidance on the use of intrapartum antibiotics, see the NICE 16 guideline on Antibiotics for early-onset neonatal infection.
17 1.5 Identifying infection in women with P-PROM
18 1.5.1 Use a combination of clinical assessment and biomedical tests to 19 diagnose intrauterine infection in women with P-PROM.
20 1.5.2 Do not use any of the following in isolation to confirm or exclude 21 intrauterine infection in women with P-PROM:
22 a single test of C-reactive protein 23 white blood cell count 24 cardiotocography.
1 At the time of consultation (June 2015), erythromycin did not have a UK marketing authorisation for use in pregnancy. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. See the General Medical Council’s Prescribing guidance: prescribing unlicensed medicines for further information. The summaries of product characteristics for oral erythromycin recommend different dosages. The evidence reviewed for the guideline supports a dosage of 250 mg 4 times a day for prophylaxis in women with P-PROM.
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1 1.5.3 If the results of the clinical assessment or any of the biomedical 2 tests are not consistent with each other, continue to observe the 3 woman and consider repeating the tests.
4 1.6 'Rescue’ cervical cerclage
5 1.6.1 Consider ‘rescue’ cervical cerclage for women between 16+0 and 6 27+6 weeks of pregnancy with a dilated cervix and exposed, 7 unruptured fetal membranes.
8 1.6.2 Do not offer ‘rescue’ cervical cerclage to women with signs of 9 infection, active vaginal bleeding or uterine contractions.
10 1.6.3 When deciding whether to offer ‘rescue’ cervical cerclage:
11 take into account gestational age and the extent of cervical 12 dilatation 13 discuss with a consultant obstetrician and consultant 14 paediatrician.
15 1.6.4 Explain to women for whom ‘rescue’ cervical cerclage is being 16 considered (and their family members or carers as appropriate):
17 about the risks of the procedure 18 that it aims to delay the birth, and so increase the likelihood of 19 the baby surviving and of reducing serious neonatal morbidity.
20 1.7 Diagnosing preterm labour for women with intact 21 membranes
22 1.7.1 Explain to women reporting symptoms of preterm labour who have 23 intact membranes (and their family members or carers as 24 appropriate):
25 about the clinical assessment and diagnostic tests that are 26 available 27 how the clinical assessment and diagnostic tests are carried out
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1 what the benefits, risks and possible consequences of the 2 clinical assessment and diagnostic tests are, including the 3 consequences of false positive and false negative test results 4 taking into account gestational age.
5 1.7.2 Offer a clinical assessment to women reporting symptoms of 6 preterm labour who have intact membranes. This should include:
7 clinical history taking 8 the observations described for the initial assessment of a woman 9 in labour in recommendation 1.4.2 of the NICE guideline on 10 intrapartum care 11 a speculum examination (followed by a digital vaginal 12 examination2 if the extent of cervical dilatation cannot be 13 assessed).
14 1.7.3 If the clinical assessment suggests that the woman is in suspected 15 preterm labour and she is 29+6 weeks pregnant or less, advise 16 treatment for preterm labour as described in sections 1.8–1.10.
17 1.7.4 If the clinical assessment suggests that the woman is in suspected 18 preterm labour and she is 30+0 weeks pregnant or more, consider 19 transvaginal ultrasound measurement of cervical length as a 20 diagnostic test to determine likelihood of birth within 48 hours. Act 21 on the results as follows:
22 if cervical length is more than 15 mm, explain to the woman that 23 it is unlikely that she is in preterm labour and: 24 discuss with her the benefits and risks of going home 25 compared with continued monitoring and treatment in hospital 26 advise her that if she does decide to go home, she should 27 return if symptoms suggestive of preterm labour recur
2 Be aware that if a swab for fetal fibronectin testing is anticipated (see recommendation 1.7.5), the swab should be taken before any digital vaginal examination.
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1 if cervical length is 15 mm or less, view the woman as being in 2 diagnosed preterm labour and offer treatment as described in 3 sections 1.8–1.10.
4 1.7.5 Consider fetal fibronectin testing as a diagnostic test to determine 5 likelihood of birth within 48 hours for women who are 30+0 weeks 6 pregnant or more if transvaginal ultrasound measurement of 7 cervical length is indicated but is not available or not acceptable. 8 Act on the results as follows:
9 if fetal fibronectin testing is negative, explain to the woman that it 10 is unlikely that she is in preterm labour and: 11 discuss with her the benefits and risks of going home 12 compared with continued monitoring and treatment in hospital 13 advise her that if she does decide to go home, she should 14 return if symptoms suggestive of preterm labour recur 15 if fetal fibronectin testing is positive, view the woman as being in 16 diagnosed preterm labour and offer treatment as described in 17 sections 1.8–1.10.
18 1.7.6 If a woman in suspected preterm labour who is 30+0 weeks 19 pregnant or more does not have transvaginal ultrasound 20 measurement of cervical length or fetal fibronectin testing to 21 exclude preterm labour, offer treatment consistent with her being in 22 diagnosed preterm labour (see sections 1.8–1.10).
23 1.7.7 Do not use transvaginal ultrasound measurement of cervical length 24 and fetal fibronectin testing in combination to diagnose preterm 25 labour.
26 1.7.8 Ultrasound scans should be performed by healthcare professionals 27 with training in, and experience of, transvaginal ultrasound 28 measurement of cervical length.
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1 1.8 Maternal corticosteroids
2 1.8.1 For women between 23+0 and 23+6 weeks of pregnancy who are in 3 suspected or established preterm labour, are having a planned 4 preterm birth or have P-PROM (see section 1.3), discuss with the 5 woman (and her family members or carers as appropriate) the use 6 of maternal corticosteroids in the context of her individual 7 circumstances.
8 1.8.2 Consider maternal corticosteroids for women between 24+0 and 9 26+0 weeks of pregnancy who are in suspected or established 10 preterm labour, are having a planned preterm birth or have P- 11 PROM (see section 1.3).
12 1.8.3 Offer maternal corticosteroids to women between 26+1 and 13 35+6 weeks of pregnancy who are in suspected, diagnosed or 14 established preterm labour, are having a planned preterm birth or 15 have P-PROM.
16 1.8.4 When offering or considering maternal corticosteroids, discuss with 17 the woman (and her family members or carers as appropriate):
18 how corticosteroids may help 19 the potential risks associated with them.
20 1.8.5 Do not routinely offer repeat courses of maternal corticosteroids, 21 but take into account:
22 whether the interval since the end of last course is more than 23 10 weeks 24 gestational age 25 the likelihood of birth within 48 hours.
26 1.9 Magnesium sulfate for neuroprotection
27 1.9.1 Offer intravenous magnesium sulfate for neuroprotection of the 28 baby to women between 24+0 and 34+0 weeks of pregnancy who 29 are:
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1 in established preterm labour or 2 having a planned preterm birth within 24 hours.
3 1.9.2 Give a 4 g intravenous bolus of magnesium sulfate over 4 15 minutes, followed by an intravenous infusion of 1 g per hour until 5 the birth or for 24 hours (whichever is sooner).
6 1.9.3 For women on magnesium sulfate, monitor for clinical signs of 7 magnesium toxicity at least every 4 hours by recording pulse, blood 8 pressure, respiratory rate and deep tendon (for example, patellar) 9 reflexes.
10 1.9.4 If a woman has or develops oliguria or other signs of renal failure:
11 monitor more frequently for magnesium toxicity 12 think about reducing the dose of magnesium sulfate.
13 1.10 Tocolysis
14 1.10.1 Take the following factors into account when making a decision 15 about whether to start tocolysis:
16 whether the woman is in suspected or diagnosed preterm labour 17 other clinical features (for example, bleeding or infection) which 18 might suggest that stopping labour is contraindicated 19 gestational age at presentation 20 likely benefit of maternal corticosteroids (see section 1.8) 21 availability of neonatal care (need for transfer to another unit) 22 the preference of the woman.
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1 1.10.2 Offer calcium channel blockers for tocolysis3 to women between 2 24+1 and 34+0 weeks of pregnancy who have intact membranes and 3 are in suspected or diagnosed preterm labour.
4 1.10.3 If calcium channel blockers are contraindicated, offer oxytocin 5 receptor antagonists for tocolysis.
6 1.10.4 Be aware that there is an absence of evidence about all tocolytic 7 medicines before 26+0 weeks of pregnancy.
8 1.10.5 Do not offer betamimetics for tocolysis.
9 1.11 Fetal monitoring
10 Monitoring options: cardiotocography and intermittent auscultation 11 1.11.1 Discuss with women in suspected, diagnosed or established 12 preterm labour (and their family members or carers as appropriate):
13 the purpose of fetal monitoring 14 the clinical decisions it informs at different gestational ages 15 if appropriate, the option not to monitor the fetal heart rate (for 16 example, at the threshold of viability).
17 1.11.2 Involve a senior obstetrician in discussions about whether and how 18 to monitor the fetal heart rate in women between 23+0 and 19 24+6 weeks of pregnancy.
20 1.11.3 Explain the different fetal monitoring options to the woman (and her 21 family members or carers as appropriate), being aware that:
22 there is limited evidence about the usefulness of specific 23 cardiotocography features suggestive of hypoxia or acidosis in 24 preterm babies
3 Although this use is common in UK clinical practice, at the time of consultation (June 2015), calcium channel blockers did not have a UK marketing authorisation for this indication. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. See the General Medical Council’s Prescribing guidance: prescribing unlicensed medicines for further information.
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1 the available evidence is broadly consistent with that for babies 2 born at term (see section 1.10 in the NICE guideline on 3 intrapartum care) 4 a normal cardiotocography trace is reassuring and indicates that 5 the baby is coping well with labour, but an abnormal trace does 6 not necessarily indicate that fetal hypoxia or acidosis is present.
7 1.11.4 Explain to the woman (and her family members or carers as 8 appropriate) that there is an absence of evidence that using 9 cardiotocography improves the outcomes of preterm labour for the 10 woman or the baby compared with intermittent auscultation.
11 1.11.5 Offer women in established preterm labour but with no other risk 12 factors (see section 1.10 in the NICE guideline on intrapartum care) 13 fetal heart rate monitoring using either:
14 cardiotocography using external ultrasound or 15 intermittent auscultation.
16 Take the woman's preferences into account when deciding on 17 choice of monitoring option.
18 1.11.6 For guidance on using intermittent auscultation for fetal heart rate 19 monitoring, see recommendation 1.10.1 in the NICE guideline on 20 intrapartum care.
21 Fetal scalp electrode 22 1.11.7 Do not use a fetal scalp electrode for fetal heart rate monitoring if 23 the woman is less than 34+0 weeks pregnant unless all of the 24 following apply:
25 it is not possible to monitor the fetal heart rate using either 26 external cardiotocography or intermittent auscultation 27 it has been discussed with a senior obstetrician 28 the benefits are likely to outweigh the potential risks
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1 the alternatives (immediate birth, intermittent ultrasound and no 2 monitoring) have been discussed with the woman and are 3 unacceptable to her.
4 1.11.8 Discuss with the woman (and her family members or carers as 5 appropriate) the possible use of a fetal scalp electrode between 6 34+0 and 36+6 weeks of pregnancy if it is not possible to monitor the 7 fetal heart rate using either external cardiotocography or 8 intermittent auscultation.
9 Fetal blood sampling 10 1.11.9 Do not carry out fetal blood sampling if the woman is less than 11 34+0 weeks pregnant.
12 1.11.10 Discuss with the woman the possible use of fetal blood sampling 13 between 34+0 and 36+6 weeks of pregnancy if the benefits are likely 14 to outweigh the potential risks.
15 1.11.11 When offering fetal blood sampling, discuss this with the woman as 16 described in recommendation 1.10.41 in the NICE guideline on 17 intrapartum care, and advise her that if a blood sample cannot be 18 obtained a caesarean section is likely.
19 1.12 Mode of birth
20 1.12.1 Discuss the general benefits and risks of caesarean section and 21 vaginal birth with women in suspected or diagnosed preterm labour 22 and women with P-PROM (and their family members or carers as 23 appropriate) – see recommendation 1.1.2.1 in the NICE guideline 24 on caesarean section.
25 1.12.2 Explain to women in suspected or diagnosed preterm labour and 26 women with P-PROM about the benefits and risks of caesarean 27 section that are specific to gestational age. In particular, highlight 28 the difficulties associated with performing a caesarean section for a 29 preterm birth, especially the increased likelihood of a vertical 30 uterine incision and the implications of this for future pregnancies.
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1 1.12.3 Explain to women in suspected or diagnosed preterm labour that 2 there are no known benefits or harms for the baby from caesarean 3 section, but the evidence is very limited.
4 1.12.4 Consider caesarean section for women presenting in suspected or 5 diagnosed preterm labour between 26+0 and 36+6 weeks of 6 pregnancy with breech presentation, and explain to the woman 7 that:
8 caesarean section for breech presentation for preterm babies is 9 common but not universal practice 10 this practice is based on an extrapolation of evidence of best 11 management for breech presentation for babies born at term 12 there is some evidence that there may be a large reduction in 13 perinatal mortality associated with caesarean section for preterm 14 babies with breech presentation, but overall the evidence is 15 inconclusive.
16 1.13 Timing of cord clamping for preterm babies (born 17 vaginally or by caesarean section)
18 1.13.1 If a preterm baby needs to be moved away from the mother for 19 resuscitation, or there is significant maternal bleeding:
20 consider milking the cord and 21 clamp the cord as soon as possible.
22 1.13.2 Wait at least 30 seconds, but no longer than 3 minutes, before 23 clamping the cord of preterm babies if the mother and baby are 24 stable.
25 1.13.3 Position the baby at or below the level of the placenta before 26 clamping the cord.
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1 2 Implementation: getting started
2 This section will be completed in the final guideline using information provided 3 by stakeholders during consultation.
4 To help us complete this chapter, please use the comments form to give us 5 your views on these questions:
6 1. Which areas will have the biggest impact on practice and be 7 challenging to implement? Please say for whom and why.
8 2. What would help users overcome any challenges? (For example, 9 existing practical resources or national initiatives, or examples of 10 good practice.)
11 3 Research recommendations
12 The Guideline Committee has made the following recommendations for 13 research, based on its review of evidence, to improve NICE guidance and 14 patient care in the future. The Guideline Committee’s full set of research 15 recommendations is detailed in the full guideline.[hyperlink to be added for 16 final publication]
17 3.1 Prophylactic cervical cerclage compared with 18 prophylactic vaginal progesterone for preventing 19 preterm birth
20 What is the clinical effectiveness of prophylactic cervical cerclage alone 21 compared with prophylactic vaginal progesterone alone and with both 22 strategies together for preventing preterm birth in women with a short cervix 23 and a history of spontaneous preterm birth?
24 Why this is important 25 Preterm birth causes significant neonatal morbidity and mortality, as well as 26 long-term disability. Therefore strategies for preventing preterm birth are 27 important. There are recognised risk factors for preterm birth, and so 28 interventions can be offered to women with these risk factors. Both
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1 prophylactic cervical cerclage and prophylactic vaginal progesterone are 2 effective in preventing preterm birth in women with a short cervix and a history 3 of preterm birth, but there is limited evidence on which is more effective, and 4 the relative risks and benefits (including costs) of each. More randomised 5 research is needed to compare the relative effectiveness of prophylactic 6 cervical cerclage and prophylactic vaginal progesterone in improving both 7 neonatal and maternal outcomes. This will help women and healthcare 8 professionals to make an informed decision about which is the most effective 9 prophylactic option.
10 3.2 Diagnosing preterm prelabour rupture of membranes 11 (P-PROM)
12 What is the diagnostic accuracy and utility of tests (placental alpha- 13 microglobulin-1, insulin-like growth factor binding protein-1, fetal fibronectin, 14 panty-liner with polymer-embedded strip) for diagnosing P-PROM?
15 Why this is important 16 P-PROM is relatively common. In the absence of clear pooling of amniotic 17 fluid in the vagina, clinical assessment cannot be conclusive about the 18 diagnosis. There is limited evidence about the accuracy of diagnostic tests 19 (placental alpha-microglobulin-1, insulin-like growth factor binding protein-1, 20 fetal fibronectin, panty-liner with polymer-embedded strip), and the results of 21 available studies are inconclusive. Making the correct diagnosis is important, 22 because women with a true positive diagnosis or a false negative diagnosis 23 could benefit from prophylactic antibiotics, whereas women with a false 24 positive diagnosis (who have intact fetal membranes) could be harmed by 25 inappropriate use of prophylactic antibiotics. More research on the diagnostic 26 accuracy of the various tests should evaluate both the performance of the 27 tests themselves and their impact on management and outcome. Studies 28 should include subgroup analysis broken down by different gestational ages.
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1 3.3 Identifying infection in women with preterm prelabour 2 rupture of membranes (P-PROM)
3 What is the diagnostic accuracy of serial C-reactive protein testing to identify 4 chorioamnionitis in women with P-PROM?
5 Why this is important 6 Identifying infection in women with P-PROM is needed to allow appropriate 7 management. Early diagnosis of infection allows consideration of therapeutic 8 strategies (including antibiotics and/or early birth). Effective treatment of 9 infection is particularly important given that sepsis is a common direct cause 10 of maternal death. There is currently limited evidence that serial C-reactive 11 protein testing might be useful, but the Committee is aware that this strategy 12 is in common practice. Evidence from diagnostic studies is needed about the 13 accuracy of serial C-reactive protein testing for identifying chorioamnionitis, 14 which is one of the most common and serious infective complications of P- 15 PROM.
16 3.4 Effectiveness of ‘rescue’ cerclage
17 What is the clinical effectiveness of ‘rescue’ cerclage in improving outcomes 18 for women at risk of preterm birth?
19 Why this is important 20 There is some evidence from randomised studies that ‘rescue’ cerclage might 21 be effective in improving neonatal outcomes in women with a dilated cervix 22 and exposed, unruptured fetal membranes. However, there is uncertainty 23 about the magnitude of this effect. The full consequences of this strategy and 24 the subgroups of women at risk of preterm labour who might particularly 25 benefit are not known. A randomised controlled trial would best address this 26 question, but a national registry of the most critical outcomes (neonatal 27 mortality and morbidity, maternal morbidity) could also be considered for 28 women who did not want to participate in a randomised trial but who opted for 29 ‘rescue’ cerclage.
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1 3.5 Magnesium sulfate for neuroprotection: bolus plus 2 infusion compared with bolus alone
3 What is the clinical effectiveness of a bolus plus infusion of magnesium sulfate 4 compared with a bolus alone for preventing neurodevelopmental injury in 5 babies born preterm?
6 Why this is important 7 There is evidence from randomised studies that magnesium sulfate has 8 neuroprotective properties for the baby when given to women who will deliver 9 preterm up to 34+0 weeks of pregnancy. However, there is uncertainty about 10 the best method of administering magnesium sulfate for this purpose, with 11 different studies using different strategies. There are significant advantages 12 for the woman and for reducing healthcare costs if a bolus is as effective as a 13 bolus plus infusion, because magnesium sulfate has side effects for the 14 woman, and more monitoring is needed for infusion, with additional 15 associated healthcare costs. A randomised controlled trial would best address 16 this question by assessing the effects of each method on neonatal and 17 maternal outcomes.
18 4 Other information
19 4.1 Scope and how this guideline was developed
20 NICE guidelines are developed in accordance with a scope that defines what 21 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 Committee (see section 5), which reviewed the evidence and developed the recommendations.
The methods and processes for developing NICE guidelines are described on the NICE website.
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1
2 4.2 Related NICE guidance
3 Details are correct at the time of consultation on the guideline (June 2015). 4 Further information is available on the NICE website.
5 Published
6 General
7 Patient experience in adult NHS services (2012) NICE guideline CG138 8 Medicines adherence (2009) NICE guideline CG76
9 Condition-specific
10 Diabetes in pregnancy (2015) NICE guideline NG3 11 Antenatal and postnatal mental health (2014) NICE guideline 192 12 Intrapartum care (2014) NICE guideline CG190 13 Postnatal care (2014) NICE guideline CG37 14 Antibiotics for early-onset neonatal infection (2012) NICE guideline CG149 15 Drainage, irrigation and fibrinolytic therapy (DRIFT) for post-haemorrhagic 16 hydrocephalus in preterm infants (2011) NICE interventional procedure 17 guidance 412 18 Caesarean section (2011) NICE guideline CG132 19 Multiple pregnancy (2011) NICE guideline CG129 20 Quitting smoking in pregnancy and following childbirth (2010) NICE 21 guideline PH26 22 Pregnancy and complex social factors (2010) NICE guideline CG110 23 Hypertension in pregnancy (2010) NICE guideline CG107 24 Neonatal jaundice (2010) NICE guideline CG98 25 Induction of labour (2008) NICE guideline CG70 26 Antenatal care (2008) NICE guideline CG62 27 Laparoscopic cerclage for prevention of recurrent pregnancy loss due to 28 cervical incompetence (2007) NICE interventional procedure guidance 228 29 Endovascular closure of patent ductus arteriosus (2004) NICE 30 interventional procedure guidance 97
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1 Vision Amniotic Leak Detector to assess unexplained vaginal wetness in 2 pregnancy (2013) NICE medical technology guidance MTG15
3 Under development 4 NICE is developing the following guidance:
5 Intrapartum care for high risk women. NICE guideline. Publication expected 6 November 2017.
7
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1 5 The Guideline Committee, National
2 Collaborating Centre and NICE project team,
3 and declarations of interests
4 5.1 Guideline Committee
5 Judi Barratt 6 Clinical midwife specialist, Worcester Royal Hospital
7 Paul Eunson 8 Consultant Paediatric Neurologist & Honorary Senior Lecturer, Royal Hospital 9 for Sick Children, Edinburgh
10 Jane Hawdon 11 Consultant Neonatologist, Barts Health NHS Trust
12 Jane Norman (Chair) 13 Professor of Maternal and Fetal Health, Director of the Tommy's Centre for 14 Maternal and Fetal Health, University of Edinburgh MRC Centre for 15 Reproductive Health Queen's Medical Research Institute
16 Philip Owen 17 Consultant Obstetrician and Gynaecologist, North Glasgow NHS Trust
18 Jane Plumb 19 Lay member
20 Farrah Pradhan 21 Lay member
22 Marianne Rowntree 23 Midwife, Plymouth Hospitals NHS Trust
24 Meekai To 25 Consultant in Fetal Medicine and Obstetrics, Kings College Hospital
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1 Martin Ward Platt 2 Consultant Paediatrician (neonatal medicine), The Newcastle upon Tyne 3 Hospitals
4 Louise Weaver-Lowe 5 Neonatal nurse, Central Manchester University Hospitals NHS Trust
6 5.2 National Collaborating Centre for Women’s and 7 Children’s Health
8 Ebenezer Ademisoye 9 Health Economist (from February 2015)
10 Zosia Beckles 11 Information Scientist (from October 2014)
12 Liz Bickerdike 13 Research Assistant (until September 2013)
14 Shona Burman-Roy 15 Senior Research Fellow
16 Amy Wang 17 Research Fellow (from January 2015)
18 Anne Carty 19 Project Manager (from March 2015)
20 Melanie Davies 21 Clinical Director for Women’s Health (from December 2014)
22 Maryam Gholitabar 23 Research Fellow
24 Paul Jacklin 25 Senior Research Fellow – Health Economist
26 David James 27 Clinical Director for Women’s Health (until November 2014)
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1 Juliet Kenny 2 Project Manager (until March 2015)
3 Rosalind Lai 4 Information Scientist (until October 2014)
5 Hugo Pedder 6 Statistician (from September 2014)
7 Grammati Sarri 8 Senior Research Fellow and Guideline Lead (from October 2015)
9 Roz Ullman 10 Senior Research Fellow and Clinical Lead for Midwifery (until April 2014)
11 5.3 NICE project team
12 Christine Carson 13 Guideline Lead
14 Phil Alderson 15 Clinical Adviser
16 Sarah Stephenson 17 Guideline Commissioning Manager (from March 2015)
18 Oliver Bailey 19 Guideline Commissioning Manager (until March 2015)
20 Besma Nash 21 Guideline Coordinator
22 Steven Barnes 23 Technical Lead
24 Ross Maconachie 25 Health Economist
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1 Lyn Knott 2 Editor
3 Jessica Fielding 4 Public Involvement Adviser
5 5.4 Declarations of interests
6 The following members of the Guideline Committee made declarations of 7 interests. All other members of the Committee stated that they had no 8 interests to declare. The conflicts of interest policy (2007) was followed until 9 September 2014, when an updated policy was published.
Member Interest declared Type of Decision interest taken Judi Barratt Chair of local guidelines group Non-personal Declare and which recently updated preterm pecuniary participate birth guidelines which included recommendations on diagnosis of preterm pre-labour rupture of membranes Jane Hawdon Receives payment for Personal Declare and occasional medico-legal work pecuniary participate (cases undertaken have involved representing both claimants and defendants) in which JH has provides evidenced-based feedback on the outcomes of preterm labour and birth. Jane Hawdon Honoraria and funding to cover Personal Declare and expenses received from Chiesi pecuniary participate to speak at and chair meetings Jane Hawdon Honoraria for invited published Personal Declare and articles and book chapters on pecuniary participate neonatal care of preterm babies. Payment from BBC for work as medical advisor to ‘Holby City’ regarding aspects of neonatal care of premature babies. Jane Hawdon Funding for expenses and Personal Declare and hospitality received from pecuniary participate sponsors with no known interest in the products covered in the scope of this guideline to speak at a conference in Athens. Jane Hawdon Spoke at Academy of Breast Personal Declare and Feeding Medicine Conference in financial non- participate
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USA on the topics not related to specific the scope of the guideline and received funding to cover travel and accommodation from the organisation. The conference was supported by industry sponsorship (manufacturers of products unrelated to the scope of the guideline). Jane Norman Receives funding to cover Personal Declare and (Chair) expenses from British Maternal pecuniary participate and Fetal Medicine Society, Society of Gynaecological Investigation (USA) and Global Alliance to Prevent Prematurity and Stillbirth (USA) to attend executive committee meetings. Jane Norman Received funding to cover Personal Declare and (Chair) expenses from March of Dimes pecuniary participate (a not-for-profit organisation in USA whose aim is to improve the health of babies by preventing birth defects, premature birth, and infant mortality) to attend meeting in December 2012 on preterm birth. Jane Norman Received funding to cover Personal Declare and (Chair) expenses from Royal College of pecuniary participate Obstetrics and Gynaecology and the Obstetrical and Gynaecological Society of Malaysia for lectures given in Malaysia on preterm birth in 2013 Jane Norman Received hospitality from Besins Personal Declare and (Chair) Healthcare while attending pecuniary participate Advisory Board meeting in 2013 on Cervical Incompetence and Preterm Birth but declined honorarium and additional hospitality that was offered after the meeting. Jane Norman Received travel expenses from Personal Declare and (Chair) 88° Congresso Nazionale / pecuniary participate SIGO to attend a meeting in Italy. At the meeting JN spoke on the topic of preventing spontaneous preterm delivery. Jane Norman Received funding to cover travel Personal Declare and (Chair) expenses and registration from pecuniary participate European Society for Preterm Birth to attend a meeting in
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Svenborg to speak on the topic of progesterone to prevent preterm labour, arguing in support of the intervention. Jane Norman Received funding to cover Personal Declare and (Chair) registration from European pecuniary participate Board of Gynecology and Obstetrics to attend a meeting in Glasgow to speak on the topic of progesterone to prevent preterm labour, arguing against the use of the intervention. Jane Norman Received hospitality while Personal Declare and (Chair) attended a meeting hosted by pecuniary participate the Royal College of Obstetricians and Gynaecologists in Glasgow. Jane Norman University of Edinburgh receives Non-personal Declare and (Chair) funding from UK government pecuniary participate agencies in payment for reports produced by JN on maternal deaths (less than £5000 received since 2010), from Preglem (a small drug company with an interest in obstetric and gynaecological drugs) for consultancy work undertaken by JN (less than £5000 received between 2010-12) and from charities and other non- commercial organisations for research undertaken by JN on various aspects of pregnancy problems. Jane Norman Centres recruiting to Non-personal Declare and (Chair) OPPTIMUM (a clinical trial led pecuniary participate by JN) receive fibronectin ‘kits’ manufactured by Hologic at a reduced price. OPPTIMUM and EMPOWaR (clinical trials led by JN) receive free investigational medicinal products and placebos from Besins Healthcare and Merck. Jane Norman University of Edinburgh receives Non-personal Declare and (Chair) funding from Chief Scientist pecuniary participate Office (part of the Scottish Government Health and Social Care Directorates), SANDS (Stillbirth and Neonatal Death Society) and Tommy’s (charity that funds research into stillbirth, preterm birth and miscarriage
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and provides information to parents) for research undertaken by JN on interventions to reduce stillbirth. Jane Norman University of Edinburgh receives Non-personal Declare and (Chair) Medical Research pecuniary participate Council/National Institute for Health Research funding for a clinical trial investigating the use of vaginal progesterone to prevent preterm birth (OPPTIMUM) led by JN. Jane Norman Undertook unpaid consultancy Personal Declare and (Chair) work for Hologic (manufacturer non- participate of products relating to preterm pecuniary labour and birth). Jane Norman Co-author of journal article Personal Declare and (Chair) entitled ‘Strategies for non- participate prevention of preterm birth’ that pecuniary provides overview of interventions to prevent preterm birth Jane Norman Co-author of published study Personal Declare and (Chair) article on use of progesterone non- participate for the prevention of preterm pecuniary birth in twin pregnancy (STOPPIT). Jane Norman Member of the board of Equality Personal Declare and (Chair) Challenge Unit (a charity that non-financial participate aims to further and support non-specific equality and diversity for staff and students in higher education institutions across the UK and in colleges in Scotland). Jane Norman Receives funding to act as a Personal Declare and (Chair) member of a clinical advisory financial non- participate board of PDC Biotech specific developing a drug to delay or halt preterm labour (PDC31- a synthetic octapeptide FP receptor modulator, which has been shown to induce uterine smooth muscle relaxation and delay parturition in preclinical studies). Jane Norman Member of an independent data Non-personal Declare and (Chair) monitoring committee for a study financial non- participate of retosiban to treat preterm specific labour. The study is being undertaken by GlaxoSmithKline and the company will reimburse Edinburgh University for any travel expenses incurred by JN
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while undertaking this work. Jane Norman Co-author of a paper about Personal Declare and (Chair) quantitative fetal fibronectin non-financial participate screening in asymptomatic non-specific women at high risk of preterm birth (yet to be published) Jane Norman Edinburgh University received Non-personal Declare and (Chair) funding for an expert witness financial non- participate report JN submitted to Irish specific General Medical Council. Jane Norman Participates in the March of the Personal Declare and (Chair) Dimes/International Federation non-financial participate of Gynecology and Obstetrics specific (FIGO) working group on preterm birth. Jane Norman Co-author of a letter entitled Personal Declare and (Chair) ‘Variation in Management of non-financial participate Women in Threatened Preterm specific Labour’ published in the Archives of Disease of Childhood Pub Med ID -PMID: 25526911. Jane Norman Written chapter on preterm birth Personal Declare and (Chair) published in book ‘Challenging non-financial participate Concepts in Obstetrics and specific Gynaecology’. The authors are Stock SJ, Norman JE, the title is "Fetal fibronectin and cervical ultrasound in prediction of preterm labour". The book chapter has been submitted but is unlikely to appear in print for several months Jane Norman Co-author of a paper accepted Personal Declare and (Chair) for publication in British Journal non-financial participate of Obstetrics and Gynaecology non-specific on the accuracy of quantitative fetal fibronectin testing to predict preterm birth. Jane Norman Co-author of paper accepted for Personal Declare and (Chair) publication in American Journal non-financial participate of Pathology on mouse model of non-specific preterm birth titled ‘Ultrasound- guided intrauterine injection of lipopolysaccharide as a novel model of preterm birth in the mouse’. Phillip Owen Receives payment for medico- Personal Declare and legal work (cases undertaken pecuniary participate have involved representing both claimants and defendants) in which PO provides expert
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opinion in court on obstetric and intrapartum care including the outcomes of preterm labour and birth – last 12 months Phillip Owen Receives small honoraria from Personal Declare and European Journal of Obstetrics pecuniary participate & Gynaecology and Reproductive Biology for work as editor. Received funding to cover expenses, hospitality and products for use in clinical research from manufacturers with an interest in preterm labour and birth (historical interest only – none received in last 12 months) Phillip Owen Chair of RCOG guidelines Personal Declare and committee and edits guidelines non- participate on topics specific to the scope of pecuniary this guideline including cervical cerclarge, tocolysis and maternal corticosteroids. Phillip Owen Co-author of published study Personal Declare and article on use of progesterone non- participate for the prevention of preterm pecuniary birth in twin pregnancy (STOPPIT).
Phillip Owen Invigilated part I and II MRCOG Personal Declare and exams in Delhi, India and pecuniary participate received funding from the Royal College of Obstetricians and Gynaecologists to cover the cost of travel and accommodation expenses. Phillip Owen Spoke at a conference in Delhi, Personal Declare and India on the topic of preterm non- participate birth. pecuniary Jane Plumb Made public statements on Personal Declare and behalf of Group B Strep Support pecuniary participate (charity providing information and support to the public and health care professionals on Group B Streptococcus) on topics not specific to the scope of this guideline. Jane Plumb Co-applicant on an HTA project Non-personal Declare and comparing different strategies financial non- participate for Group B streptococcus specific prevention for women in term and preterm labour – no funds awarded yet Meekai To Author of several publications on Personal Declare and
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value of cervical length as non- participate screening test for preterm birth pecuniary and the use of cervical cerclarge. Co-author of RCOG Greentop guideline on cervical cerclarge. Meekai To Peer reviewed RCOG patient Personal Declare and information leaflet on cervical non- participate cerclage. pecuniary Meekai To Wrote review article on the topic Personal Declare and of recent advances in the non-financial participate prevention and management of specific preterm birth. Meekai To Co-investigator in a study of Personal Declare and fibronectin in asymptomatic non-financial participate women for prediction of preterm specific birth and received free fetal fibronectin kits from Hologic for this purpose. Martin Ward Receives payment for Personal Declare and Platt occasional medico-legal work pecuniary participate (cases undertaken have involved representing both claimants and defendants and working with coroners and family courts) in which MW-P has provided expert feedback on aspects of perinatal care including the management of preterm birth from a paediatric perspective. Martin Ward Received payment for Personal Declare and Platt consultancy work from pecuniary participate Mothercare Plc on aspects of care not specific to the scope of this guideline. Receives payment from Archives of Disease and Childhood for work as deputy editor. Receives payment from Tees Child Death Overview Panel for work as Independent Chair. Martin Ward Reviewer for the Health Personal Declare and Platt Technology Assessment stream non- participate of the National Institute for pecuniary Health Research. Martin Ward Reviews obstetric and perinatal Personal Declare and Platt research papers for a variety of non- participate journals. Clinical Director of the pecuniary Regional Maternity Survey Office (part of Public Health England). Audit lead for the
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Northern Neonatal Network. Martin Ward Member of the Northern Personal Declare and Platt Maternity Strategic Network. non- participate Member of HTA funded study pecuniary BRACELET (Bereavement in the context of randomised controlled trials) steering group. Martin Ward Chair of the Ethics Advisory Personal Declare and Platt Board for Tinn2 study of non- participate azithromycin for preterm babies. pecuniary Member of the Royal College of Paediatrics and Child Health media panel. Chair of the Tiny Lives Trust (charity supporting neonatal care in Newcastle). Louise Participated in the development Personal Declare and Weaver-Lowe of local maternity and neonatal non- participate guidelines. Proofread preterm pecuniary birth booklet published by Tommy’s (charity that funds research into stillbirth, premature birth and miscarriage and provides information to parents). Louise Editing two chapters of a book Personal Declare and Weaver-Lowe for student nurses being non-financial participate produced by between University specific of Salford and Royal Manchester Children’s Hospital. The chapters contain two case studies of premature infants. 1
2
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