Reddy Uma M, Sandoval Grecio J, Tita Alan T N, Silver Robert M, Mallett Gail, Hill Kim, El-Sayed Yasser Y, Rice Madeline Murguia, Wapner Ronald J, Rouse Dwight J, Saade George R, Thorp John M, Chauhan Suneet P, Costantine Maged M, Chien Edward K, Casey Brian M, Srinivas Sindhu K, Swamy Geeta K, Simhan Hyagriv N, Macones George A, Grobman William A
Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (Reddy).
The George Washington University Biostatistics Center, Washington, DC (Sandoval and Rice).
Am J Obstet Gynecol MFM. 2024 Dec;6(12):101508. doi: 10.1016/j.ajogmf.2024.101508. Epub 2024 Sep 30.
Following the results of the A Randomized Trial of Induction Versus Expectant Management trial, which demonstrated a reduction in cesarean delivery with no increase in adverse perinatal outcomes after elective induction of labor in low-risk nulliparous patients at 39 weeks of gestation compared with expectant management, the use of induction of labor has increased. Current evidence is insufficient to recommend mid- to high-dose regimens over low-dose regimens for routine induction of labor.
This study aimed to evaluate the association between oxytocin regimen and cesarean delivery and an adverse perinatal composite outcome in low-risk nulliparous patients undergoing induction of labor at ≥39 weeks of gestation.
This was a secondary analysis of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network's A Randomized Trial of Induction Versus Expectant Management randomized trial. Patients who received a mid- to high-dose oxytocin regimen (starting or incremental increase >2 mU/min) were compared with those who received a low-dose oxytocin regimen (starting and incremental increase ≤2 mU/min). The co-primary outcomes for this secondary analysis were (1) cesarean delivery and (2) composite of perinatal death or severe neonatal complications. Multivariate Poisson regression was used to estimate adjusted relative risks and 97.5% confidence intervals for the co-primary endpoints and 95% confidence intervals for binomial outcomes, and multinomial logistic regression was used to estimate adjusted odds ratios and 95% adjusted relative risks for multinomial outcomes.
Of 6106 participants enrolled in the primary trial, 2933 underwent induction of labor with oxytocin: 861 in the mid- to high-dose group and 2072 in the low-dose group. The lower frequency of cesarean delivery in the mid- to high-dose group than in the low-dose group (20.3% vs 25.2%, respectively; relative risk, 0.81; 95% confidence interval, 0.69-0.94) was not significant after adjustment (adjusted relative risk, 0.90; 97.5% confidence interval, 0.76-1.07). The composite of perinatal death or severe neonatal complications was more frequent in the mid- to high-dose group than in the low-dose group (6.7% vs 4.3%, respectively; relative risk, 1.55; 95% confidence interval, 1.13-2.14) and remained significant after adjustment (adjusted relative risk, 1.61; 97.5% confidence interval, 1.11-2.35). Most cases in the composite were from the respiratory support (5.2% in the mid- to high-dose group vs 3.1% in the low-dose group) component, with an increase in transient tachypnea in newborns (3.8% in the mid- to high-dose group vs 2.5% in the low-dose group; adjusted relative risk, 1.63; 95% confidence interval, 1.04-2.54). The duration of neonatal respiratory support for 1 day was significantly longer in the mid- to high-dose group than in the low-dose group (3.5% vs 1.4%, respectively; adjusted relative risk, 2.59; 95% confidence interval, 1.52-4.39). However, support beyond 1 day was not different between the 2 groups. Compared with the low-dose group, the mid- to high-dose group had a higher operative vaginal delivery rate (10.0% vs 7.0%, respectively; adjusted relative risk, 1.54; 95% confidence interval, 1.18-2.00) and shorter duration of time from start of oxytocin to delivery (crude median: 12 hours [interquartile range, 8-17] vs 13 hours [interquartile range 9-19], respectively; adjusted median difference: -2 [95% CI, -2 to -1]; P<.001).
The use of mid-to high-dose oxytocin regimens for induction of labor in nulliparas at ≥39 weeks of gestation was not associated with a lower cesarean delivery rate or improved neonatal outcomes compared with the use of low-dose oxytocin regimens. Although the use of mid- to high-dose oxytocin regimens was associated with a shorter duration of labor, there was an increase in self-limited neonatal respiratory support and no difference in cesarean delivery rates. More evidences are needed to define the magnitude of potential maternal and neonatal benefits and risks associated with oxytocin regimens.
在一项关于引产与期待治疗的随机试验结果表明,与期待治疗相比,在孕39周时对低风险初产妇进行择期引产可降低剖宫产率且不增加围产期不良结局后,引产的使用有所增加。目前的证据不足以推荐在常规引产中使用中高剂量方案而非低剂量方案。
本研究旨在评估催产素方案与剖宫产以及≥39周妊娠接受引产的低风险初产妇围产期不良复合结局之间的关联。
这是对尤妮斯·肯尼迪·施赖弗国家儿童健康与人类发展研究所母胎医学单位网络的引产与期待治疗随机试验的二次分析。将接受中高剂量催产素方案(起始或递增剂量>2 mU/分钟)的患者与接受低剂量催产素方案(起始和递增剂量≤2 mU/分钟)的患者进行比较。本次二次分析的共同主要结局为:(1)剖宫产;(2)围产期死亡或严重新生儿并发症的复合结局。采用多变量泊松回归估计共同主要终点的调整相对风险和97.5%置信区间以及二项式结局的95%置信区间,采用多项逻辑回归估计多项结局的调整比值比和95%调整相对风险。
在纳入主要试验的6106名参与者中,2933人接受了催产素引产:中高剂量组861人,低剂量组2072人。中高剂量组剖宫产频率低于低剂量组(分别为20.3%和25.2%;相对风险,0.81;95%置信区间,0.69 - 0.94),但调整后无显著差异(调整相对风险,0.90;97.5%置信区间,0.76 - 1.07)。中高剂量组围产期死亡或严重新生儿并发症的复合结局比低剂量组更常见(分别为6.7%和4.3%;相对风险,1.55;95%置信区间,1.13 - 2.14),调整后仍有显著差异(调整相对风险,1.61;97.5%置信区间,1.11 - 2.35)。复合结局中的大多数病例来自呼吸支持部分(中高剂量组为5.2%,低剂量组为3.1%),新生儿短暂性呼吸急促增加(中高剂量组为3.8%,低剂量组为2.5%;调整相对风险,1.63;95%置信区间,1.04 - 2.54)。中高剂量组新生儿呼吸支持持续1天的时间显著长于低剂量组(分别为3.5%和1.4%;调整相对风险,2.59;95%置信区间,1.52 - 4.39)。然而,两组超过1天的支持情况无差异。与低剂量组相比,中高剂量组手术阴道分娩率更高(分别为10.0%和7.0%;调整相对风险,1.54;95%置信区间,1.18 - 2.00),且从催产素开始使用到分娩的时间更短(粗略中位数:分别为12小时[四分位间距,8 - 17]和13小时[四分位间距9 - 19];调整中位数差异:-2[95% CI,-2至-1];P <.001)。
与使用低剂量催产素方案相比,在≥39周妊娠的初产妇中使用中高剂量催产素方案引产与较低的剖宫产率或改善的新生儿结局无关。尽管使用中高剂量催产素方案与较短的产程相关,但自限性新生儿呼吸支持增加且剖宫产率无差异。需要更多证据来确定与催产素方案相关的潜在母婴益处和风险的程度。