Sequential use of foley catheter and misoprostol versus misoprostol alone for induction of labor: a multicenter randomized controlled trial.

IF 3.1 2区医学 Q1 OBSTETRICS & GYNECOLOGY

American Journal of Obstetrics & Gynecology Mfm Pub Date : 2025-08-25 DOI:10.1016/j.ajogmf.2025.101769

Saule Issenova, Dilfuza Sultanmuratova, Gulzhan Issina, Zhupar Nakhanova, Anel Kenzhegaliyeva, Rukset Attar

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引用次数: 0

Abstract

Background: Labor induction is a critical intervention used when prolonging pregnancy poses risks to maternal or fetal health. While combined methods of cervical ripening have been studied, evidence specifically regarding sequential use (as opposed to simultaneous administration) remains limited.

Objective: To compare the efficacy and safety of a sequential labor induction method (Foley catheter followed by misoprostol) versus misoprostol alone in term pregnancies.

Study design: This multicenter, randomized controlled trial (NCT06249815) was conducted at 2 hospitals in Almaty, Kazakhstan. A total of 400 women with singleton term pregnancies, cephalic presentation, and unfavorable cervices (Modified Bishop Score ≤6) requiring labor induction were enrolled. Participants were randomly assigned to: PRIMARY OUTCOME: Vaginal delivery.

Secondary outcomes: Cesarean delivery, uterine hyperstimulation, fetal distress, Apgar scores, postpartum hemorrhage, chorioamnionitis, perineal trauma, operative vaginal birth, blood transfusion, and labor augmentation.

Results: The sequential method significantly increased the probability of vaginal delivery compared to misoprostol alone (77.5% vs 69.5%; adjusted RR=1.16; 95% CI: 1.04-1.29; P=.009). The total dose of misoprostol required was significantly lower in the sequential group (P<.001). A higher incidence of chorioamnionitis was observed in the sequential group (OR=3.82; 95% CI: 1.05-13.9; P=.03).

Conclusion: The sequential method increases the probability of vaginal delivery while requiring a lower total misoprostol dose, without increasing the rate of major maternal or neonatal complications. However, it may be associated with a higher risk of chorioamnionitis, which warrants further investigation. These findings support its consideration as a clinically effective and pharmacologically conservative alternative for labor induction in women with an unfavorable cervix.

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顺序使用Foley导管和米索前列醇与单独使用米索前列醇诱导分娩：一项多中心随机对照试验。

背景：引产是当延长妊娠对母体或胎儿健康构成危险时使用的关键干预措施。虽然对宫颈成熟的联合方法进行了研究，但关于顺序使用（与同时给药相反）的具体证据仍然有限。目的：比较序贯引产方法（Foley导尿管加米索前列醇）与单用米索前列醇在足月妊娠中的疗效和安全性。研究设计：该多中心随机对照试验（[试验注册号为盲法审查]）在哈萨克斯坦阿拉木图的两家医院进行。本研究共纳入400例单胎足月妊娠、头位表现和不良服务（修正Bishop评分≤6）需要引产的妇女。•A组（n=200）： Foley导管插入12-18小时，随后口服米索前列醇。•B组（n=200）：单独口服米索前列醇。主要结局：阴道分娩。次要结局：剖宫产、子宫过度刺激、胎儿窘迫、Apgar评分、产后出血、绒毛膜羊膜炎、会阴创伤、手术阴道分娩、输血、助产。结果：顺序法与单独使用米索前列醇相比，阴道分娩的概率显著增加（77.5% vs. 69.5%；调整后RR = 1.16;95% CI: 1.04-1.29; p = 0.009）。顺序治疗组所需的米索前列醇总剂量显著降低（p < 0.001）。序贯组羊膜绒毛膜炎发生率较高（OR = 3.82;95% CI: 1.05-13.9; p = 0.03）。结论：序贯法增加了阴道分娩的可能性，同时需要较低的米索前列醇总剂量，未增加产妇或新生儿主要并发症的发生率。然而，它可能与绒毛膜羊膜炎的高风险有关，这需要进一步调查。这些发现支持其作为临床有效和药理学上保守的替代引产妇女不利的宫颈。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

American Journal of Obstetrics & Gynecology Mfm Medicine-Medicine (all)

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.