Department of Obstetrics and Gynaecology, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand (Drs Wise, Thompson, and Marriott).
Department of Obstetrics and Gynaecology, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand (Drs Wise, Thompson, and Marriott); Department of Paediatrics: Child and Youth Health, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand (Drs Thompson and Battin and Ms Wilson).
Am J Obstet Gynecol MFM. 2023 Jun;5(6):100958. doi: 10.1016/j.ajogmf.2023.100958. Epub 2023 Apr 6.
Approximately 1 in 4 pregnant women undergo induction of labor. Meta-analyses have shown that mechanical methods of induction of labor are safe and effective, as is starting induction in an outpatient setting. However, few studies have evaluated outpatient balloon catheter induction in comparison with pharmacologic methods.
This study aimed to determine whether women who underwent outpatient induction of labor with a balloon catheter would have a lower cesarean delivery rate than women who underwent inpatient induction of labor with vaginal prostaglandin E2 without an increase in adverse maternal or neonatal events.
This was a superiority randomized controlled trial. The eligibility criteria were pregnant women (nullipara and multipara) with a live singleton fetus in vertex presentation with any medical comorbidity who underwent planned induction of labor at term and who had an initial modified Bishop Score of 0 to 6 at 1 of 11 public maternity hospitals in New Zealand. The intervention groups were outpatient single balloon catheter induction in comparison with inpatient vaginal prostaglandin E2 induction. The primary hypothesis was that participants who started their induction at home with a balloon catheter would have a lower risk for cesarean delivery than participants who started their induction with prostaglandins and remained in hospital throughout. The primary outcome was cesarean delivery rate. Participants were randomized using a centralized secure online randomization website in a 1:1 ratio, stratified by parity and hospital. The participants and outcome assessors were not blinded to group allocation. An intention-to-treat analysis with adjustment for stratification variables was used.
A total of 539 participants were randomized to outpatient balloon catheter induction, and 548 participants were randomized to inpatient prostaglandin induction; the mode of birth was reported for all participants. The cesarean delivery rate was 41.0% among participants allocated to outpatient balloon induction and 35.2% among those allocated to inpatient prostaglandin induction (adjusted odds ratio, 1.27; 95% confidence interval, 0.98-1.65). Women in the outpatient balloon catheter group were more likely to have artificial rupture of membranes and to received oxytocin and an epidural. No differences were found in the rates of adverse maternal or neonatal events.
Outpatient balloon catheter induction was not found to reduce the cesarean delivery rate when compared with inpatient vaginal prostaglandin E2 induction. The use of balloon catheters in an outpatient setting does not seem to increase the rate of adverse events for mothers or babies and can be offered routinely.
大约有四分之一的孕妇需要进行引产。荟萃分析表明，机械引产方法是安全有效的，门诊进行引产也是如此。然而，很少有研究比较门诊球囊导管引产与药物引产方法。
本研究旨在确定与门诊阴道前列腺素 E2 引产相比，门诊球囊导管引产是否会降低剖宫产率，同时不增加母婴不良事件。
这是一项优效性随机对照试验。纳入标准为在新西兰 11 家公立妇产医院之一接受足月计划引产的孕妇（初产妇和经产妇），单胎头位，伴有任何合并症，初始改良 Bishop 评分 0 至 6。干预组为门诊单球囊导管引产与住院阴道前列腺素 E2 引产。主要假设是在家中使用球囊导管开始引产的参与者剖宫产风险低于使用前列腺素并全程住院的参与者。主要结局为剖宫产率。参与者按 1:1 比例，按产次和医院分层，通过中央安全在线随机化网站进行随机分组。参与者和结局评估者对分组情况不知情。采用意向治疗分析，并对分层变量进行调整。
共有 539 名参与者被随机分配至门诊球囊导管引产组，548 名参与者被随机分配至住院前列腺素引产组；所有参与者均报告了分娩方式。门诊球囊导管引产组的剖宫产率为 41.0%，住院前列腺素引产组为 35.2%（调整后的优势比，1.27；95%置信区间，0.98-1.65）。门诊球囊导管组的产妇更有可能行人工破膜，并接受催产素和硬膜外麻醉。两组产妇和新生儿的不良事件发生率无差异。
与住院阴道前列腺素 E2 引产相比，门诊球囊导管引产并未降低剖宫产率。在门诊环境中使用球囊导管似乎不会增加母婴不良事件的发生率，可常规使用。
