• Aude Girault, Loïc Sentilhes, Raoul Desbrière, Paul Berveiller, Diane Korb, Charline Bertholdt, Julie Carrara, Norbert Winer, Eric Verspyck, Eric Boudier, Tiphaine Barjat, Gilles Levy, Georges Emmanuel Roth, Gilles Kayem, Mona Massoud, Caroline Bohec, Paul Guerby, Elie Azria, Julie Blanc, Hélène Heckenroth, Jessica Rousseau, Charles Garabedian, Camille Le Ray, and collaborators of the STOPOXY trial and the Groupe de Recherche en Obstétrique et Gynécologie (GROG).
• Université Paris Cité, Inserm UMR 1153, Equipe EPOPé, Paris, France; Department of Obstetrics and Gynecology, Port-Royal Maternity Hospital, AP-HP, Cochin Hospital, FHU PREMA, Paris, France. Electronic address: aude.girault@aphp.fr.
• Lancet. 2023 Dec 2; 402 (10417): 209121002091-2100.

BackgroundOxytocin is effective in reducing labour duration but can be associated with fetal and maternal complications that could potentially be reduced by discontinuing the treatment during labour. We aimed to assess the impact of discontinuing oxytocin during active labour on neonatal morbidity.MethodsSTOPOXY was a multicentre, randomised, open-label, controlled, superiority trial conducted in 21 maternity units in France. Participants who received oxytocin before 4 cm dilation were randomly assigned 1:1 to either discontinuous oxytocin (oxytocin infusion stopped beyond a cervical dilation equal to or greater than 6 cm) or continuous oxytocin (administration of oxytocin continued until delivery). Randomisation was stratified by centre and parity. The primary outcome, neonatal morbidity, was assessed at birth using a composite variable defined by an umbilical arterial pH at birth less than 7·10, a base excess greater than 10 mmol/L, umbilical arterial lactates greater than 7 mmol/L, a 5-min Apgar score less than 7, or admission to the neonatal intensive care unit. Efficacy and safety was assessed in participants who were randomly assigned (excluding those who withdrew consent or were deemed ineligible after randomisation) and had reached a cervical dilation of at least 6 cm. This trial is registered with ClinicalTrials.gov, NCT03991091.FindingsOf 2459 participants randomly assigned between Jan 13, 2020, and Jan 24, 2022, 2170 were eligible to receive the intervention and were included in the final modified intention-to-treat analysis. The primary outcome occurred for 102 (9·6%) of 1067 participants (95% CI 7·9 to 11·5) in the discontinuous oxytocin group and for 101 (9·2%) of 1103 participants (7·6 to 11·0) in the continuous oxytocin group; absolute difference 0·4% (95% CI -2·1 to 2·9); relative risk 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.InterpretationAmong participants receiving oxytocin in early labour, discontinuing oxytocin when the active phase is reached does not clinically or statistically significantly reduce neonatal morbidity compared with continuous oxytocin.FundingFrench Ministry of Health and the Département de la Recherche Clinique et du Développement de l'Assistance Publique-Hôpitaux de Paris.Copyright © 2023 Elsevier Ltd. All rights reserved.

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