Randomised trial of cord clamping and initial stabilisation at very preterm birth

Objectives: For very preterm births, to compare alternatives policies for umbilical cord clamping and immediate neonatal care. Design: Parallel group randomised (1:1) trial, using sealed opaque numbered envelopes. Setting: Eight UK tertiary maternity units. Participants: 261 women expected...

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Bibliographic Details
Main Authors: Duley, Lelia, Dorling, Jon, Pushpa-Rajah, Angela, Oddie, Sam J., Yoxall, Charles W., Schoonakker, Bernard, Bradshaw, Lucy, Mitchell, Eleanor J., Fawke, Joe
Format: Article
Published: BMJ 2017
Subjects:
Online Access:https://eprints.nottingham.ac.uk/44309/
Description
Summary:Objectives: For very preterm births, to compare alternatives policies for umbilical cord clamping and immediate neonatal care. Design: Parallel group randomised (1:1) trial, using sealed opaque numbered envelopes. Setting: Eight UK tertiary maternity units. Participants: 261 women expected to have a livebirth before 32 weeks, and their 276 babies. Interventions: Cord clamping after at least two minutes and immediate neonatal care with cord intact, or clamping within 20 seconds and immediate neonatal care after clamping. Main outcome measures: Intraventricular haemorrhage (IVH), death before discharge. Results: 132 women (137 babies) were allocated clamping ≥2 minutes and neonatal care cord intact, and 129 (139) clamping ≤20 and neonatal care after clamping; 6 mother infant dyads were excluded (2, 4) as birth was after 35+6 weeks, 1 withdrew (death data only available) (0, 1). Median gestation was 28.9 weeks for those allocated clamping ≥2 minutes, and 29.2 for those allocated clamping ≤20 seconds. Median time to clamping was 120 and 11 seconds respectively. 7 of 135 infants (5.2%) allocated clamping ≥2 minutes died and 15 of 135 (11.1%) allocated clamping ≤20 seconds; risk difference (RD) -5.9% (95% confidence interval -12.4% to 0.6%). Of livebirths, 43 of 134 (32%) had IVH versus 47 of 132 (36%) respectively; RD -3.5% (-14.9% to 7.8%). There were no clear differences in other outcomes for infants or mothers. Conclusions: This is promising evidence that clamping after at least 2 minutes and immediate neonatal care with cord intact at very preterm birth may improve outcome; a large trial is urgently needed.