Oxytocin 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. STOPOXY 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 , . Of 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. Among 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. French Ministry of Health and the Département de la Recherche Clinique et du Développement de l'Assistance Publique–Hôpitaux de Paris.

中文翻译：

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活跃分娩时停用催产素对新生儿发病率的影响：一项开放标签、多中心、随机试验

催产素可有效缩短产程时间，但可能与胎儿和母体并发症有关，通过在产程期间停止治疗可能会减少这些并发症。我们的目的是评估活跃分娩期间停用催产素对新生儿发病率的影响。STOPOXY 是一​​项在法国 21 个妇产科单位进行的多中心、随机、开放标签、对照、优效性试验。在宫颈扩张 4 厘米之前接受催产素的参与者被随机分配为间断催产素（催产素输注在宫颈扩张等于或大于 6 厘米后停止）或连续催产素（持续使用催产素直至分娩）。随机化按中心和奇偶数分层。主要结局是新生儿发病率，在出生时使用复合变量进行评估，该变量定义为出生时脐动脉 pH 值小于 7·10、碱过剩大于 10 mmol/L、脐动脉乳酸大于 7 mmol/L、 5 分钟阿普加评分低于 7，或入院新生儿重症监护病房。对随机分配的参与者（不包括那些撤回同意或随机分配后被视为不合格的参与者）和宫颈扩张至少 6 厘米的参与者进行了疗效和安全性评估。该试验已在 , 注册。在 2020 年 1 月 13 日至 2022 年 1 月 24 日期间随机分配的 2459 名参与者中，2170 名参与者有资格接受干预，并被纳入最终修改后的意向治疗分析中。主要结局发生在间断催产素组 1067 名参与者中的 102 名 (9·6%) (95% CI 7·9 至 11·5) 以及 1103 名参与者中的 101 名 (9·2%) (7·6 至 11 ·0) 在连续催产素组中；绝对差异 0·4%（95% CI –2·1 至 2·9）；相对风险 1·0（95% CI 0·8 至 1·4）。两组安全人群之间的不良事件没有临床显着差异。在分娩早期接受催产素的参与者中，与持续使用催产素相比，在达到活跃期时停止催产素并不会在临床上或统计学上显着降低新生儿发病率。法国卫生部和巴黎公立医院研究与发展部。