Oxytocin regimen used for induction of labor and pregnancy outcomes

IF 3.8 2区 医学 Q1 OBSTETRICS & GYNECOLOGY
Uma M. Reddy MD, MPH , Grecio J. Sandoval PhD , Alan T.N. Tita MD, PhD , Robert M. Silver MD , Gail Mallett RN, MS, CCRC , Kim Hill RN, BSN , Yasser Y. El-Sayed MD , Madeline Murguia Rice PhD , Ronald J. Wapner MD , Dwight J. Rouse MD , George R. Saade MD , John M. Thorp Jr MD , Suneet P. Chauhan MD, Hon DSc , Maged M. Costantine MD , Edward K. Chien MD , Brian M. Casey MD , Sindhu K. Srinivas MD, MSCE , Geeta K. Swamy MD , Hyagriv N. Simhan MD , George A. Macones MD, MSCE , William A. Grobman MD, MBA
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Grobman MD, MBA","doi":"10.1016/j.ajogmf.2024.101508","DOIUrl":null,"url":null,"abstract":"<div><h3>BACKGROUND</h3><div>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.</div></div><div><h3>OBJECTIVE</h3><div>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.</div></div><div><h3>STUDY DESIGN</h3><div>This was a secondary analysis of the <em>Eunice Kennedy Shriver</em> 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 &gt;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.</div></div><div><h3>RESULTS</h3><div>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]; <em>P</em>&lt;.001).</div></div><div><h3>CONCLUSION</h3><div>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.</div></div>","PeriodicalId":36186,"journal":{"name":"American Journal of Obstetrics & Gynecology Mfm","volume":"6 12","pages":"Article 101508"},"PeriodicalIF":3.8000,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"American Journal of Obstetrics & Gynecology Mfm","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2589933324002349","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

BACKGROUND

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.

OBJECTIVE

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.

STUDY DESIGN

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.

RESULTS

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).

CONCLUSION

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.
用于引产的催产素方案与妊娠结局。
研究背景ARRIVE 试验结果表明,与预产期管理相比,妊娠 39 周的低风险无阴道患者在选择性引产(IOL)后,剖宫产率降低,围产期不良结局无增加。目前的证据不足以推荐常规 IOL 使用中高剂量而非低剂量方案:我们试图评估在妊娠 39 周或 39 周以上接受 IOL 手术的低风险无子宫患者中,催产素方案与剖宫产和围产期不良综合结局的相关性:这是NICHD母胎医学单位网络ARRIVE随机试验的二次分析。使用中高剂量催产素方案(MHD;起始剂量或递增剂量>2 mU/min)引产的患者与使用低剂量催产素方案(LD;起始剂量和递增剂量≤2 mU/min)引产的患者进行了比较。该二次分析的共同主要结果为:1)剖宫产;2)围产期死亡或严重新生儿并发症。多变量泊松回归用于估计共同主要终点的调整相对风险(aRR)和97.5%置信区间(CI),二项结果的置信区间为95%,多项式逻辑回归用于估计多项式结果的调整几率比(aOR)和95%置信区间:在6106名参加初选的参与者中,2933人接受了催产素引产:861人在MHD组,2072人在LD组。与 LD 组相比,MHD 组的剖宫产率较低(20.3% 对 25.2%,RR 0.81,95%CI (0.69-0.94)),但经调整后并无显著性差异(aRR 0.90,97.5%CI (0.76-1.07))。与 LD 组相比,MHD 组围产期死亡或严重新生儿并发症的综合发生率更高(6.7% 对 4.3%,RR 1.55,95%CI (1.13-2.14)),调整后仍有显著性(aRR 1.61,97.5%CI (1.11-2.35))。综合病例中的大多数病例来自呼吸支持(5.2% 对 3.1%)部分,新生儿一过性呼吸过速病例增加(3.8% 对 2.5%,aRR 1.63,95%CI (1.04-2.54))。与 LD 组相比,MHD 组新生儿呼吸支持一天的持续时间明显较长(3.5% 对 1.4%,aRR 2.59,95%CI (1.52-4.39));但是,支持一天以上的时间在两组之间没有差异。与 LD 组相比,MHD 组的阴道分娩手术率更高(10.0% 对 7.0%,aRR 1.54,95%CI (1.18-2.00)),从开始使用催产素到分娩的时间更短(粗中位数(四分位间范围)12(8-17)小时对 13(9-19)小时,调整后的中位数差异-2(-2 到-1),p 结论:MHD 组的阴道分娩手术率更高,从开始使用催产素到分娩的时间更短(粗中位数(四分位间范围)12(8-17)小时对 13(9-19)小时,调整后的中位数差异-2(-2 到-1),p):与低剂量方案相比,在妊娠≥39周的无子宫产妇中使用中高剂量催产素方案进行IOL与改善产妇或新生儿预后无关。虽然中大剂量催产素方案与产程缩短有关,但自限性新生儿呼吸支持增加,剖宫产率没有差异。需要更多证据来确定催产素方案对孕产妇和新生儿的潜在益处和风险。
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来源期刊
CiteScore
7.40
自引率
3.20%
发文量
254
审稿时长
40 days
期刊介绍: The American Journal of Obstetrics and Gynecology (AJOG) is a highly esteemed publication with two companion titles. One of these is the American Journal of Obstetrics and Gynecology Maternal-Fetal Medicine (AJOG MFM), which is dedicated to the latest research in the field of maternal-fetal medicine, specifically concerning high-risk pregnancies. The journal encompasses a wide range of topics, including: Maternal Complications: It addresses significant studies that have the potential to change clinical practice regarding complications faced by pregnant women. Fetal Complications: The journal covers prenatal diagnosis, ultrasound, and genetic issues related to the fetus, providing insights into the management and care of fetal health. Prenatal Care: It discusses the best practices in prenatal care to ensure the health and well-being of both the mother and the unborn child. Intrapartum Care: It provides guidance on the care provided during the childbirth process, which is critical for the safety of both mother and baby. Postpartum Issues: The journal also tackles issues that arise after childbirth, focusing on the postpartum period and its implications for maternal health. AJOG MFM serves as a reliable forum for peer-reviewed research, with a preference for randomized trials and meta-analyses. The goal is to equip researchers and clinicians with the most current information and evidence-based strategies to effectively manage high-risk pregnancies and to provide the best possible care for mothers and their unborn children.
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