south eastern trust 27579 - prevention and management o… · 7.0 diagnosing preterm prelabour...

The Prevention and Management of Preterm Labour of 14

SOUTH EASTERN TRUST

Title: The Prevention and Management of Preterm Labour

Author(s)

Dr Sunneva Gilmore (O&G Trainee), Dr Penny Hill (O&G Consultant)

Ownership: South Eastern Health & Social Care Trust

Approval by: Woman & Acute Child Health Approval date:

May 2017

Operational Date:

May 2017 Next Review:

May 2020

Version No. 2 Supersedes Prevention of preterm labour and birth Management of Preterm labour (February 2014) The antenatal use of Magnesium Sulfate for Fetal Neuroprotection in Preterm Delivery (April 2015)

Key Words Preterm Labour

Links to other Policies

1.0 INTRODUCTION 1.1 Preterm delivery is a major cause of neonatal morbidity and mortality. Attempting to

stop, or at least delay, the onset of preterm labour (PTL) can allow several interventions which have been shown to improve outcomes.

This guideline aims to cover:

- Prophylactic vaginal progesterone and prophylactic cervical cerclage - Antenatal steroid use - Tocolysis for prevention of PTL - MgSO4 use for neuroprotection

In all cases of potential preterm delivery inform and involve senior on-call personnel in obstetrics, paediatrics, and where necessary anaesthetists. The labour ward midwife in charge should co-ordinate and NNU should be kept informed.

WACH Maternity PRO (32) 2017


1.2 The use of MgSO4 in preterm delivery is a relatively new practice where pre-

eclampsia is not an indication for its use. Guidelines and studies used as a basis are:

ARCH guidelines - Antenatal Magnesium Sulfate Prior to Preterm Birth for Neuroprotection of the Fetus, Infant and Child;

SOGC guidelines - Magnesium Sulfate for Fetal Neuroprotection; and

Various Cochrane Collaboration Reviews on this particular topic.

NICE guideline. Preterm labour and birth. November 2015. 2.0 DEFINITIONS / SCOPE OF THE PROTOCOL

This guideline will apply to any woman who is admitted with suspected, diagnosed or established preterm labour, or with planned preterm delivery.

3.0 ROLES AND RESPONSIBILITIES In all cases of imminent preterm delivery of gestational age ≤32+0 weeks, inform and involve senior on-call personnel in obstetrics, anaesthetics and for UHD paediatrics. The labour ward midwife in charge should co-ordinate and NNU should be kept informed.

4.0 INFORMATION & SUPPORT 4.1 When giving information and support to women at increased risk of preterm labour,

with suspected, diagnosed or established preterm labour, or having a planned preterm birth (and their family members or carers as appropriate):

give information and support as early as possible, taking into account the likelihood of preterm birth and the status of labour

give both oral and written information (RCOG PIL premature labour Oct 2014 https://www.rcog.org.uk/globalassets/documents/patients/patient-information-leaflets/pregnancy/pi-premature-labour.pdf )

describe the symptoms and signs of preterm labour

Explain to the woman about the care she may be offered.

4.2 For women who are having a planned preterm birth or are offered treatment for preterm labour in line with the sections below (7–9.), provide information and support that includes:

information about the likelihood of the baby surviving and other outcomes (including long-term outcomes) and risks for the baby

Explaining about the neonatal care of preterm babies, including location of care depending upon gestation. This includes a copy of the “Having an Extremely Premature Baby” for pts between 23 and 27 weeks gestation

explaining about the immediate problems that can arise when a baby is born preterm, in addition to possible long-term consequences of prematurity for the baby

https://www.rcog.org.uk/globalassets/documents/patients/patient-information-leaflets/pregnancy/pi-premature-labour.pdf



ongoing opportunities to talk about and state their wishes about resuscitation of the baby

An opportunity to tour the neonatal unit and to speak to a neonatologist or paediatrician.

5.0 PROPHYLACTIC VAGINAL PROGESTERONE AND PROPHYLACTIC

CERVICAL CERCLAGE Prophylactic vaginal progesterone has been shown to be beneficial in women with a history of preterm delivery and a shortened cervix. In contrast women with a past history of PPROM may benefit from vaginal progesterone but the evidence is not as compelling. NICE suggests we:

Offer a choice of either prophylactic vaginal progesterone or prophylactic cervical cerclage to women:

with a history of spontaneous preterm birth or mid-trimester loss between 16+0 and 34+0 weeks of pregnancy and

In whom a transvaginal ultrasound scan has been carried out between 16+0 and 24+0

weeks of pregnancy that reveals a cervical length of less than 25 mm.

Discuss the benefits and risks of prophylactic progesterone and cervical cerclage with the woman and take her preferences into account.

5.1 Offer prophylactic vaginal progesterone to women with no history of spontaneous preterm birth or mid-trimester loss in whom a transvaginal ultrasound scan has been carried out between 16+0 and 24+0 weeks of pregnancy that reveals a cervical length of less than 25 mm.

5.2 The recommended dose of progesterone is 200mg PV daily.

5.3 Consider prophylactic cervical cerclage or prophylactic vaginal progesterone for women

had preterm prelabour rupture of membranes (P-PROM) in a previous pregnancy or a history of cervical trauma.

in whom a transvaginal ultrasound scan has been carried out between 16+0 and 24+0

weeks of pregnancy that reveals a cervical length of less than 25 mm and who have either:

6.0 ‘RESCUE’ CERVICAL CERCLAGE

6.1 Do not offer 'rescue' cervical cerclage to women with: signs of infection, active vaginal bleeding or uterine contractions.

Consider 'rescue' cervical cerclage for women between 16+0 and 27+6 weeks with a dilated cervix and exposed, unruptured fetal membranes: take into account gestational age (benefits are likely to be greater for earlier gestations) and the extent of cervical dilatation

Discuss with a consultant obstetrician and consultant paediatrician.


6.2 Explain to women for whom ‘rescue’ cervical cerclage is being considered about the risks of the procedure, that it aims to delay the birth, and so increase the likelihood of the baby surviving and of reducing serious neonatal morbidity.

7.0 DIAGNOSING PRETERM PRELABOUR RUPTURE OF MEMBRANES (P-PROM) (Please refer to the current South Eastern Trust guideline)

8.0 DIAGNOSING PRETERM LABOUR FOR WOMEN WITH INTACT MEMBRANES

Explain to women reporting symptoms of preterm labour who have intact membranes about the clinical assessment and diagnostic tests that are available. Explain the benefits, risks and consequences of false positive and false negative test results.

Offer a clinical assessment to women reporting symptoms of preterm labour who have intact membranes. This should include:

Clinical history taking

Observations for the initial assessment of a woman in labour

Speculum examination (followed by a digital vaginal examination (VE) if the extent of cervical dilatation cannot be ascertained).

If clinical assessment suggests that the woman is in suspected preterm labour and she is 29+6weeks pregnant or less, advise treatment for preterm labour (see sections 7-9). If clinical assessment suggests the woman is in suspected preterm labour and she is 30+0 weeks pregnant or more, trained practitioners in transvaginal ultrasound scan may measure cervical length to determine the likelihood of birth within 48 hours.

If cervical length is 15mm or less, consider the woman as being in diagnosed preterm labour. Offer treatment as described in sections 7-9.

Consider partosure testing as a diagnostic test to determine the likelihood of birth within 48 hours for women who are 30 weeks or more pregnant. Act accordingly:

If partosure is negative, explain to the mother it is unlikely that she is in preterm labour. Consider alternative diagnosis. Discuss risks and benefits of going home compared with monitoring in hospital.

If partosure is positive, view the woman as diagnosed preterm labour and offer treatment.

Do not use partosure and transvaginal cervical length in combination to diagnose preterm labour.

A partosure test may be carried out between at the gestational age of 24weeks to 34weeks+6 days. (as per manufacturer OLm)


9.0 ANTENATAL STEROID USE 9.1 The use of antenatal steroids has been shown to reduce the incidence of

respiratory distress syndrome (RDS), and also other complications of prematurity such as intraventricular haemorrhage.

9.2 Evidence for the use of antenatal steroids is strongest between 24+0 and 34+6

weeks gestation. a) Offer steroids to women between 26+0 and 33+6 weeks gestation who are

in suspected, diagnosed or established preterm labour, are having a planned preterm birth or have P-PROM.

b) Consider maternal steroids between 34+0 and 35+6 weeks gestation who are in suspected, diagnosed or established preterm labour, are having a planned preterm birth or have P-PROM. (NICE 2015)

9.3 At the extreme of prematurity, data is scarce and each case should be taken

individually with decisions regarding its use made at senior level. Antenatal corticosteroids are most effective in reducing RDS in pregnancies that

deliver 24 hours after, and up to 7 days after administration of the second dose of steroids. Antenatal steroids reduce neonatal death within the first 24 hours and therefore should still be given if delivery is expected within this time. Caution should be exercised in giving corticosteroid therapy to women with systemic infection including tuberculosis or sepsis.

9.4 In summary the use of antenatal steroids should be considered:

- women at risk of either spontaneous or iatrogenic preterm delivery up to 34+6

weeks, with either a singleton or multiple pregnancy

- women in whom an elective caesarean section is planned prior to 38+6 weeks - women whose pregnancy is affected by IUGR should receive steroids up to

35+6 weeks NB: women with diabetes in pregnancy and receiving antenatal steroids, the decision to consider admission for monitoring of blood sugars and management with insulin should be made as per the diabetic team. This depends on the type of diabetes and the current management of that woman’s diabetes in pregnancy.

9.5 Regimen: - Betamethasone 12mg IM in 2 doses given 24 hrs apart

- Dexamethasone 6mg IM in 4 doses each given 12 hrs apart Timing of the doses can vary but guidelines suggest that as long as 24mg of either drug is given within a 24-48hr period, any dosing regimen can be used.


9.6 Consideration of a 2nd course may be given if the first course was completed before 26+0 weeks gestation – this should be discussed with Consultant.

10.0 TOCOLYSIS USE IN PRETERM LABOUR 10.1 Tocolysis can reduce delivery of the preterm fetus for up to one week. However,

overall the use of tocolytics is beneficial if the few days gained would benefit the pregnancy for in utero transfer or steroid administration.

10.2 Do not use tocolytics if no benefit is to be gained from delaying labour. 10.3 In this unit, the tocolytic of choice is now Nifidipine. It has similar or better efficacy in

stopping labour compared to Ritodrine, with a much better side effect profile. It should be prescribed between 24+0 and 33+6 weeks gestation, to women who require Tocolysis.

(a) Consider Nifedipine for Tocolysis for women between 24+0 and 25+6 weeks of

pregnancy who have intact membranes and are in suspected preterm labour (b) Offer Nifedipine for Tocolysis to women between 26+0 and 33+6 weeks of

pregnancy who have intact membranes, and are in suspected or diagnosed preterm labour. (NICE 2015)

Tocolysis should not be used where there is a contraindication to prolonging delivery (see 10.7).

10.4 Nifedipine and Atosiban are more effective tocolytics than Ritodine and have fewer

adverse effects. Nifidipine is preferable to Atosiban as it can be administered orally, requires less fetal monitoring and is cost effective. (Cochrane Database of Systemic Reviews 2008).

10.5 Maternal side effects of Nifedipine are more common at larger doses; however, they

usually pass and if this is explained to the patient, it is usually well tolerated. Side effect can include headache, flushing, dizziness, lethargy, tachycardia, palpitations, rash, purities, nausea, constipation, diarrhoea, exaggerated fall in blood pressure and reflex tachycardia.

10.6 If Nifedipine is contraindicated, offer Atosiban for Tocolysis. 10.7 Contraindications

Tocolysis should not be commenced in any condition where it would be better to expedite delivery, for example:

- Severe IUGR - Significant APH - Severe pre-eclampsia - Abnormal CTG - Abnormal end diastolic flow on umbilical artery Doppler - Intrauterine infection - Cardiac disease for example; cardiac shock, advanced aortic stenosis, within

1 month of a myocardial infarction, unstable or acute attacks of angina. - Porphyria.


10.8 The patient and fetal condition should be regularly reviewed (see below) and

tocolytics stopped if there is evidence of maternal side effects or fetal compromise. 10.9.1 Nifedipine is not licensed in pregnancy, but it is considered to be as safe as

Atosiban. The Medical Practitioner must prescribe it on a named patient basis. The patient should be informed of this.

10.9.2 Administration of Nifedipine:

The following is recommended for use in this Unit, based on consensus opinion of the Cochrane reviewers, 2008.

Nifedipine 10mgs orally, every 15 minutes until contractions stop, or for one hour (i.e. maximum 4 doses) Clinical situation and contraction frequency and length to be reviewed by SPR or Consultant at this point.

12 hours following completion of the initial dosing, prescribe Adalat Retard 40mgs, 12 hourly to a maximum of 3 doses. Monitoring whilst on Nifedipine: DAY 1 Initially maternal pulse and blood pressure and then after each additional 10mgs oral Nifedipine.Then half hourly for two hours. Continuous fetal monitoring until one hour after first oral dose of Nifedipine. If contractions have ceased may go to the Ward for 4 hourly BP, maternal pulse and fetal heart rate monitoring. DAY 2 Maternal BP, pulse and CTG to confirm fetal well-being prior to administration of each oral Nifedipine (Adalat Retard 40mgs).Half hourly maternal pulse and BP following administration for one hour.CTG to confirm fetal wellbeing after administration of Nifedipine.

11.0 USE OF MAGNESIUM SULFATE FOR NEUROPROTECTION

One of the major consequences of preterm delivery is cerebral palsy, a debilitating disease, which affects about 2-3 in every 1000 live births. Delivery at less than 34 weeks causes an increased risk of cerebral palsy – between 17-32% of all cases. Studies have shown that Magnesium Sulfate used in treatment of pre-eclampsia at a gestational age of less than 34 weeks provided neuroprotection to babies and showed a lower risk of having cerebral palsy.


Our unit will be using Magnesium Sulfate up until 33+6 weeks for neuroprotection of the fetus prior to preterm delivery, either as a planned or a spontaneous onset of labour. a) Offer intravenous Magnesium Sulfate between 24+0 and 29+6 weeks of

pregnancy to women in established preterm labour or having a planned preterm birth within 24 hours.

b) Consider in women between 30+0 and 33+6 weeks of pregnancy in established preterm labour or having a planned preterm birth within 24 hours.

11.1 KEY PRINCIPLES

11.2 Magnesium Sulfate should be administered to the mother:

In imminent preterm delivery of ≤33+6 weeks

Where imminent preterm delivery is either planned or at ≥ 4 cm dilatation

As close to 4 hours prior to a planned delivery, until delivery 11.3 Use of Magnesium Sulfate in preterm delivery should be considered where delivery

is planned or expected within 24 hours, regardless of indication for delivery or mode of delivery. It is unclear how much time exposure to Magnesium Sulfate is required to receive benefit. Studies suggest it would seem optimal if Magnesium Sulfate is given for at least 4 hrs prior to planned/expected delivery. If birth anticipated sooner than 4 hours continue to give Magnesium Sulfate as some benefit may still be gained. Do not delay delivery for administration of Magnesium Sulfate.

11.4 Administration of Magnesium Sulfate is as for pre-eclampsia:

Management should be in Delivery Suite

- Loading dose 4 g IV over 20 minutes (20% solution, i.e. 8ml of 50% Magnesium Sulfate in 12ml of 0.9% sodium chloride)

- Infusion 1g/hour until birth or for up to 24 hours. - This is administered in prefilled syringes supplied by pharmacy. - The dose is 5gm in 50 mls of fluid; therefore the rate of infusion as per syringe

driver is 10mls per hour.

If no delivery within 24 hours, a further loading dose and maintenance infusion can be administered (however there is no evidence that this is useful – discuss with Consultant) In women who do not deliver and are deemed to be at less risk of delivery, the protocol can be stopped. It can be restarted if the risk of imminent delivery again increases. It is a consultant decision, as to whether a further loading dose is required.


11.5 Monitoring required for a woman with a Magnesium Sulfate infusion; - Hourly urinary output, respiratory rate, O2 saturation and patellar reflexes (every

10 minutes for first two hours, then every 30 minutes). Stop infusion, check magnesium levels and review management with consultant if any of the following;

o Urine output <25ml/hr o Absent patellar reflexes o Respiratory rate < 10/min o Oxygen saturation <90% o Patient is unresponsive o Imminent delivery is no longer the case

If signs of magnesium toxicity;

o Stop infusion o Administer antidote of calcium gluconate (10ml of 10% solution slowly IV

over 10 minutes) If patient is to be transferred due to NNU cot constraints, this should be discussed with the accepting hospital team to make them aware of the treatment being given. Discussion with the receiving team should be in regards to the magnesium sulphate infusion being commenced. Decision on pausing the Magnesium Sulfate infusion for transfer, should be made by Obstetric registrar in discussion with the on-call Consultant. This will depend on distance for transfer, effect of Magnesium Sulfate on clinical condition e.g. hypotension and personnel available to transfer the patient. 11.6 Magnesium Sulfate and concurrent use of Nifedipine (advice from Dr C. Nelson-Piercy)

Magnesium Sulfate and concurrent use of nifedipine (as per advice from Dr C. Nelson-Piercy, Consultant Obstetric Physician, King’s College London):

Monitor blood pressure closely as use of both medications together can drop this measurement in women with abnormal blood pressure. Hypotension is the main concern with both medications and not neurological deficit

Blood pressure to be monitored as per Trust ‘Use of Tocolysis’ guideline: Day 1 - Maternal pulse and blood pressure before first dose and then after each

additional 10 mg. Then half hourly for two hours - CTG until one hour after first oral dose. Once contractions settled, then hourly

BP, pulse, and fetal monitoring.

Day 2 - Maternal BP, pulse and CTG to confirm fetal well-being prior to each

administration of nifedipine. Half hourly pulse and BP following administration for one hour. CTG after nifedipine administration.


12.0 TIMING OF CORD CLAMPING FOR PRETERM BABIES (BORN VAGINALLY OR BY CAESAREAN SECTION) 12.1 If a preterm baby needs to be moved away from the mother for resuscitation, or

there is significant maternal bleeding:

Consider milking the cord and clamp the cord as soon as possible. 12.2 Wait at least 30 seconds, but no longer than 3 minutes, before clamping the cord

of preterm babies if the mother and baby are stable. 12.3 Position the baby at or below the level of the placenta before clamping the cord. 13.0 Delivery of preterm infants and temperature regulation. 13.1 For all babies under 32 weeks the baby should be delivered into a plastic bag to

help maintain normo-thermia. All preterm infants receive a woolly hat. Temperature increase in the place of delivery is currently the subject of a QI project and may also be appropriate.

14.0 AUDIT / MONITORING 14.1 Suggestions:

Audit on the administration of prophylactic progesterone or insertion of cervical cerclage, and gestation at delivery

Audit on administration of MgSO4 for neuroprotection and follow-up for neonatal unit progress:

Apgar scores and need for resuscitation at birth

Neonatal convulsions

Intraventricular haemorrhage

Periventricular leucomalacia

Length of stay in the neonatal unit Audit on administration of Magnesium Sulfate and side effects for the mothers – is it worth giving it if the mothers are getting severe side effects? Audit on concurrent use of Magnesium Sulfate and nifedipine in regards to blood pressure. Future research for children diagnosed with cerebral palsy – how many got Magnesium Sulfate prior to delivery.

15.0 EVIDENCE BASE/REFERENCES

- RCOG Green-top Guideline No. 7 Antenatal Corticosteroids to Reduce Neonatal Mortality and Morbidity RCOG October 2010

- RCOG Green-top Guideline No. 1b Tocolysis for Women in Preterm Labour

February 2011


- Cochrane Database of Systemic Reviews 2 2008 Calcium channel blockers for inhibiting preterm labour

- The Antenatal Magnesium Sulfate for Neuroprotection Development Panel.

Antenatal magnesium sulphate prior to preterm birth for neuroprotection of the fetus, infant and child: National clinical practice guidelines. Adelaide: TheUniversityofAdelaide, 2010.

- Magee L, et al. Magnesium Sulfate for FetalNeuroprotection. JOGC, 2011:516-29.

- Doyle LW, et. al. Magnesium sulpfate for women at risk of preterm birth for neuroprotection of the fetus. Cochrane Collaboration Review, January 2010.

- UK National Statistics website: Health and Social Care, Maternity and Pregnancy Statistics. www.statistics.gov.uk

- NICE guidelines [NG25] Preterm labour and birth. November 2015.

www.nice.org.uk/guidance/ng25 - Leaflet produced by Neonatal Network Northern Ireland, Having an

Extremely Premature Baby, What it Means For you and Your Baby 2016.

- Information for you: Premature labour. RCOG. Published October 2014. https://www.rcog.org.uk/globalassets/documents/patients/patient-information-leaflets/pregnancy/pi-premature-labour.pdf

- Fetal Fibronectin Enzyme Immunoassay. Information for Healthcare Providers.

http://www.ffntest.com/pdfs/rapid_ffn_product_insert_lettersize.pdf - Partosure - Up to Date The Role of Progesterone in pregnancy maintenance.

16.0 APPENDICES

See flow chart for treatment with MgSO4 in preterm labour at the end of the guideline. Flow diagram for prevention of Preterm Birth. Flow diagram of diagnosis PTL

17.0 EQUALITY STATEMENT

In line with duties under the equality legislation (Section 75 of the Northern Ireland Act 1998), Targeting Social Need Initiative, Disability discrimination and the Human Rights Act 1998, an initial screening exercise to ascertain if this policy should be subject to a full impact assessment has been carried out. The outcome of the Equality screening for this policy is:

Major impact

http://www.statistics.gov.uk/

http://www.nice.org.uk/guidance/ng25



http://www.ffntest.com/pdfs/rapid_ffn_product_insert_lettersize.pdf


SIGNATORIES ________________________________ Date: ____________________________ Dr. P Hill Consultant Obstetrician and Gynaecologist WACH ________________________________ Date: ____________________________ Dr. D. Glenn Consultant Obstetrician and Gynaecologist Clinical Director WACH ________________________________ Date: _________________________ Mrs Zoe Boreland Head of Midwifery (SOM) WACH ________________________________ Date: ____________________________ Dr David Robinson Assistant Director WACH


Is preterm delivery (≤ 33+6

weeks) imminent?

Yes

Are there any contraindications for

administration of Magnesium Sulfate ?

No

Administer Magnesium

Sulfate

Monitor:

BP

Pulse

Respiratory rate

Patellar reflexes

Urine output

Stop infusion if:

Respiratory rate <10/min

Absent patellar reflexes

Urine output < 25ml/hr

O2 sats <90%

Delivery

Yes

No administration Magnesium

Sulfate

No

No administration of Magnesium

Sulfate

Contraindications:

Renal failure

Hypotension

Need for immediate delivery

Allergy

Hypocalcaemia

Myasthenia gravis


previous history spontaneous preterm

birth, PPROM 16 to 34 weeks or mid trimester loss or cervical trauma

Yes

Offer Transvaginal measurement of cervical length between 16

and 24 weeks

If Cervical length <25 mm offer prophylactic vaginal progesterone or

cervical cerclage

If Cervix > 25 mm repeat TV scan 4weekly until 28 weeks

No further Cervical monitoring required

No

No action

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