When to deliver small babies between 32 and 37 weeks

Not Applicable

• Conditions: Fetal growth restriction; Pregnancy and Childbirth

• Registration Number: ISRCTN76016200
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-20
• Last Update Posted: 8 January 2024
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 638

Inclusion Criteria

Current inclusion criteria as of 27/07/2020:
All criteria should be fulfilled to be eligible for randomisation:
1. Women = 18 years old
2. Pregnant with singleton non-anomalous fetuses
3. Between 32+0 and 36+6 weeks of gestation
4. Estimated fetal weight or abdominal circumference <10th percentile OR decreased by 50 percentiles since an ultrasound scan at 18+0-32+0 weeks
5. Cerebral redistribution defined as UCR >1.0 (32+0-33+6 weeks) or >0.8 (34+0-36+6 weeks) measured at least twice in any 24 hours period
6. Normal STV on cCTG (4.5 msec or above)

Previous inclusion criteria:
For screening:
1. Women = 18 years old
2. Pregnant with singleton fetuses at risk of compromise:
2.1 Between 32+0 and 36+6 weeks of gestation and
2.2 Estimated fetal weight or abdominal circumference <10th percentile OR abdominal circumference decreased by 50 percentiles from 18-22 week scan

For randomisation:
3.1 Cerebral redistribution defined as UCR z-score >1.5 (32-33+6 weeks) / >1.0 (34-36+6 weeks) and:
3.2 Normal STV on cCTG (> 4.5msec) and:
3.3 No contraindications to either trial treatment arm

Exclusion Criteria

Current exclusion criteria as of 27/07/2020:
1. Indication for immediate delivery required within 48 hours
2. Unable to give informed consent
3. Preterm prelabour rupture of the membranes (PPROM)
4. Suspected placental abruption or antepartum haemorrhage
5. Presence of reversed end diastolic flow in the Umbilical Artery

Previous exclusion criteria:
1. Indication for immediate delivery within 48 hours
2. Unable to give informed consent
3. Preterm prelabour rupture of the membranes (PPROM)
4. Suspected placental abruption or antepartum haemorrhage

Study & Design

• Study Type: Interventional
• Study Design: Not specified