نبذة مختصرة : International audience ; Background: Oxytocin is effective in reducing labor duration but can be associated with fetal and maternal complications that could potentially be reduced by discontinuing the treatment during labor. We assessed the impact of discontinuing oxytocin during active labor on neonatal morbidity. Methods: STOPOXY was a multicenter, randomized, open-label, controlled, superiority trial conducted in 21 maternity units in France. Participants who received oxytocin before 4cm dilation were randomly assigned, in a 1:1 ratio to either discontinuous oxytocin (oxytocin infusion stopped beyond a cervical dilation equal to or greater than 6cm) or continuous oxytocin (administration of oxytocin is continued until delivery). Randomization was stratified by center and parity. The primary outcome, neonatal morbidity, was assessed at birth using a composite variable defined by an umbilical arterial pH at birth <7.10 and/or a base excess >10mmol/L and/or umbilical arterial lactates>7 mmol/L and/or a 5-minute Apgar score <7 and/or admission in neonatal intensive care unit. Results: Out of the 2459 participants randomized between January 13, 2020, and January 24, 2022, 2170 were eligible to receive the intervention and were analyzed. The primary outcome occurred in 102 of 1067 women (9.6%, 95%CI(7.9 to 11.5)) in the discontinuous oxytocin group and in 101 of 1103 women (9.2%, 95%CI(7.6 to 11.0)) in the control group, absolute difference 0.004, 95%CI(-0.021 to 0.029); RR 1.0, 95%CI(0.8 to 1.4). There were no clinically significant differences in adverse events between the two groups of the safety population. Interpretation: Among participants receiving oxytocin in early labor, discontinuing oxytocin when active phase is reached does not clinically or statistically significantly reduce neonatal morbidity compared to continuous oxytocin.
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