Tang Rachel J, Bode Leah M, Baugh Kyle M, Mosesso Kelly M, Daggy Joanne K, Guise David M, Teal Evgenia, Christman Megan A, Tuskan Britney N, Haas David M
Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, IN (Tang, Bode, Baugh, Christman, Tuskan, and Haas).
Department of Biostatistics and Health Data Science, Indiana University School of Medicine, Indianapolis, IN (Mosesso, Daggy, and Guise).
AJOG Glob Rep. 2024 Jul 9;4(3):100378. doi: 10.1016/j.xagr.2024.100378. eCollection 2024 Aug.
Previous studies that suggest a shorter time from cervical ripening balloon placement to delivery with shorter total balloon placement time have excluded patients with prior cesarean deliveries.
To evaluate, in patients with a prior history of cesarean delivery undergoing cervical ripening with a double-balloon catheter, whether planned removal of device after 6 vs 12 hours would result in shorter time to vaginal delivery.
A before-and-after study was performed after a practice change occurred November 2020, shortening the planned time of double-balloon catheter placement for cervical ripening from 12 to 6 hours. Data were collected via retrospective electronic chart review. Primary outcome was time from balloon placement to vaginal delivery. Secondary outcomes included rates of cesarean delivery, maternal intraamniotic infection, and uterine rupture. Kaplan-Meier curves compared median times to delivery between the groups. A Cox proportional-hazards model was used to adjust for time of balloon placement, number of previous vaginal deliveries, and co-medications used.
From November 2018 to November 2022, 189 analyzable patients with a prior history of cesarean delivery received a double-balloon catheter for cervical ripening during their trial of labor. Patients were separated into pre- and postpolicy change groups (=91 and 98, respectively). The median time to vaginal delivery for the pregroup was 28 hours (95% CI: 26, 35) and 25 hours (95% CI: 23, 29) for those in the postgroup ( value .052). After adjusting for dilation at time of balloon placement, number of previous vaginal deliveries, and co-medication, the estimated hazard ratio for successful vaginal delivery postpolicy change was 1.89 (95% CI: 1.27, 2.81). There were no differences in rates of secondary outcomes.
In patients with prior cesarean delivery undergoing mechanical cervical ripening with a double-balloon catheter, planned removal at 6 hours compared to 12 hours may result in higher chances of successful vaginal delivery and possibly a shorter time to delivery, without increasing rates of cesarean delivery and intraamniotic infection.
先前的研究表明，从放置宫颈成熟球囊到分娩的时间较短且球囊总放置时间较短，但这些研究排除了有剖宫产史的患者。
对于有剖宫产史且使用双球囊导管进行宫颈成熟的患者，评估在6小时与12小时后计划取出装置是否会缩短阴道分娩时间。
在2020年11月实践改变后进行了一项前后对照研究，将宫颈成熟双球囊导管的计划放置时间从12小时缩短至6小时。通过回顾性电子病历审查收集数据。主要结局是从球囊放置到阴道分娩的时间。次要结局包括剖宫产率、产妇羊膜腔内感染率和子宫破裂率。采用Kaplan-Meier曲线比较两组之间的中位分娩时间。使用Cox比例风险模型对球囊放置时间、既往阴道分娩次数和使用的联合药物进行校正。
2018年11月至2022年11月，189例有剖宫产史的可分析患者在试产期间接受了双球囊导管进行宫颈成熟。患者被分为政策改变前和改变后两组（分别为91例和98例）。政策改变前组的中位阴道分娩时间为28小时（95%CI：26，35），政策改变后组为25小时（95%CI：23，29）（P值=0.052）。在对球囊放置时的宫颈扩张、既往阴道分娩次数和联合用药进行校正后，政策改变后成功阴道分娩的估计风险比为1.89（95%CI：1.27，2.81）。次要结局发生率无差异。
对于有剖宫产史且使用双球囊导管进行机械性宫颈成熟的患者，与12小时相比，6小时计划取出装置可能会增加成功阴道分娩的机会，并且可能缩短分娩时间，同时不增加剖宫产率和羊膜腔内感染率。
