Carvalho-Afonso M, Policiano C, Clode N, Ayres-de-Campos D
Department of Obstetrics and Gynaecology, Faculdade de Medicina de Lisboa, Medical School, University of Lisbon, Lisbon, Portugal.
Department of Obstetrics, Gynaecology and Reproductive Medicine, Santa Maria University Hospital, Lisbon, Portugal.
Int J Gynaecol Obstet. 2025 Aug;170(2):768-773. doi: 10.1002/ijgo.70088. Epub 2025 Mar 27.
This study evaluates the efficacy and safety of cervical ripening with a Foley catheter balloon in a cohort of women with a medical indication for labor induction.
In this prospective observational study, we evaluated 320 women with singleton term pregnancies, Bishop's score less than 6, and scheduled cervical ripening with a Foley catheter balloon. The outcomes assessed were: Bishop's score at first re-evaluation 18-24 h later, gain in Bishop's score at first re-evaluation, Bishop's score ≥6 at first re-evaluation, onset of labor in the 24 h after insertion, delivery within 24 h, delivery within 48 h, and failed labor induction. Overall success of cervical ripening was defined as achieving a favorable Bishop's score or onset of labor within 24 h. Adverse events occurring during balloon insertion or until the first re-evaluation were also documented.
At first re-evaluation 18-24 h later, 106 women (33.1%) had a Bishop's score ≥6, and the median gain in Bishop's score was 2. In the first 24 h after balloon insertion, 48 women (15%) went into labor, for an overall success rate of 48.1%. Delivery within 48 h occurred in 214 (66.9%), and failed labor induction in 38 (11.9%). Adverse events were observed in 14 women (4.4%), mainly pain/discomfort, vaginal bleeding, and balloon rupture. All were mild and required no further intervention. The risk of caesarean delivery for failed labor induction was decreased with outpatient cervical ripening (OR 0.39, 95% CI 0.16-0.86), and when an open cervix was present at the start of the process (OR 0.43, 95% CI 0.18-0.97).
Approximately half of women undergoing cervical ripening with a Foley catheter balloon achieve a favorable cervix or onset of labor within 24 h; 67% are delivered within 48 h. Adverse events are rare and mild, requiring no further intervention. Outpatient cervical ripening and an open cervix on admission are associated with higher success rates.
本研究评估在有引产医学指征的女性队列中，使用福莱氏尿管球囊进行宫颈成熟的有效性和安全性。
在这项前瞻性观察研究中，我们评估了320名单胎足月妊娠、 Bishop评分小于6且计划使用福莱氏尿管球囊进行宫颈成熟的女性。评估的结果包括：18 - 24小时后首次重新评估时的Bishop评分、首次重新评估时Bishop评分的增加、首次重新评估时Bishop评分≥6、插入后24小时内临产、24小时内分娩、48小时内分娩以及引产失败。宫颈成熟的总体成功定义为在24小时内达到良好的Bishop评分或临产。还记录了球囊插入期间或直到首次重新评估时发生的不良事件。
18 - 24小时后首次重新评估时，106名女性（33.1%）的Bishop评分≥6，Bishop评分的中位数增加为2。球囊插入后的前24小时内，48名女性（15%）临产，总体成功率为48.1%。48小时内分娩的有214名（66.9%），引产失败的有38名（11.9%）。14名女性（4.4%）观察到不良事件，主要是疼痛/不适、阴道出血和球囊破裂。所有这些均为轻度，无需进一步干预。门诊宫颈成熟（比值比0.39，95%置信区间0.16 - 0.86）以及在该过程开始时宫颈开放（比值比0.43，95%置信区间0.18 - 0.97）可降低引产失败后剖宫产的风险。
使用福莱氏尿管球囊进行宫颈成熟的女性中，约一半在24小时内宫颈状况良好或临产；67%在48小时内分娩。不良事件罕见且轻微，无需进一步干预。门诊宫颈成熟和入院时宫颈开放与更高的成功率相关。
