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

Abstract

OBJECTIVES: For very preterm births, to compare alternative 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 live birth before 32 weeks, and their 276 babies. INTERVENTIONS: Cord clamping after at least 2 min and immediate neonatal care with cord intact, or clamping within 20 s and immediate neonatal care after clamping. MAIN OUTCOME MEASURES: Intraventricular haemorrhage (IVH), death before discharge. RESULTS: 132 women (137 babies) were allocated clamping ≥2 min and neonatal care cord intact, and 129 (139) clamping ≤20 s and neonatal care after clamping; six mother-infant dyads were excluded (2, 4) as birth was after 35+6 weeks, one withdrew (death data only available) (0, 1). Median gestation was 28.9 weeks for those allocated clamping ≥2 min, and 29.2 for those allocated clamping ≤20 s. Median time to clamping was 120 and 11 s, respectively. 7 of 135 infants (5.2%) allocated clamping ≥2 min died and 15 of 135 (11.1%) allocated clamping ≤20 s; risk difference (RD) -5.9% (95% CI -12.4% to 0.6%). Of live births, 43 of 134 (32%) had IVH vs 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 min and immediate neonatal care with cord intact at very preterm birth may improve outcome; a large trial is urgently needed. TRIAL REGISTRATION: ISRCTN 21456601.