Department of Obstetrics & Gynaecology, Faculty of Medicine, Universiti Malaya, Kuala Lumpur, Malaysia.
Department of Obstetrics & Gynaecology, Faculty of Medicine, Universiti Malaya, Kuala Lumpur, Malaysia.
Am J Obstet Gynecol MFM. 2023 Nov;5(11):101142. doi: 10.1016/j.ajogmf.2023.101142. Epub 2023 Aug 27.
BACKGROUND: Planned 6- vs 12-hour placement of the double-balloon catheter for cervical ripening in labor induction hastens delivery. The Foley catheter is low-priced and typically performs at least as well as the proprietary double-balloon devices in labor induction. Maternal satisfaction with labor induction is usually inversely related to the speed of the process. OBJECTIVE: This study aimed to compare Foley balloon placement for 6 vs 12 hours in the labor induction of multiparas with unfavorable cervixes. STUDY DESIGN: A randomized controlled trial was conducted in a university hospital in Malaysia from January to October of 2022. Eligible multiparous women admitted for induction of labor for various indications were enrolled. Participant inclusion criteria were multiparity (at least 1 previous vaginal delivery of ≥24 weeks' gestation), age ≥18 years, term pregnancy >37 weeks' gestation, singleton pregnancy, cephalic presentation, intact membranes, normal fetal heart rate tracing, no significant contractions (< 2 in 10 minutes), and unfavorable cervix (Bishop score < 6). Participants were randomized after successful Foley balloon insertion for the balloon to be left in place for 6 or 12 hours of passive ripening before removal to check cervical suitability for amniotomy. The primary outcomes were the induction-to-delivery interval and maternal satisfaction with the allocated intervention assessed using a visual numerical rating scale (0-10). Secondary outcomes were derived in part from the core outcome set for trials on induction of labor (Core Outcomes in Women's and Newborn Health [CROWN]). Maternal outcomes were change in first Bishop score after intervention, use of additional method for cervical ripening, time to delivery after balloon removal, mode of delivery, indication for cesarean delivery, duration of oxytocin infusion, blood loss during delivery, presence of third- or fourth-degree perineal tear, maternal infection, use of regional analgesia in labor, length of hospital stay, intensive care unit (ICU) admission, cardiorespiratory arrest, and need for hysterectomy. The secondary neonatal outcomes were Apgar score at 1 and 5 minutes, neonatal intensive care unit (NICU) admission, cord blood pH, neonatal sepsis, birthweight, birth trauma, hypoxic-ischemic encephalopathy, or need for therapeutic hypothermia. Analyses were conducted with the t-test, Mann-Whitney U test, chi-square test, and Fisher exact test, as appropriate. RESULTS: A total of 220 women were randomized (110 to each intervention). Regarding the 2 primary outcomes, the induction-to-delivery intervals were a median (interquartile range) of 15.9 (12.0-24.0) and 21.6 (17.3-26.0) hours (P<.001), and maternal satisfaction scores were 7 (6-8) and 7 (6-8) (P=.734) for 6- and 12-hour placement, respectively. The following rates were observed for 6- and 12-hour placement, respectively: sequential use of additional cervical ripening agent (Foley reinsertion)-29 per 110 (26.4%) and 13 per 110 (11.8%) (relative risk, 2.23; 95% confidence interval, 1.23-4.10; P=.006); spontaneous balloon expulsion-22 per 110 (20.0%) and 37 per 110 (33.6%) (relative risk, 0.60; 95% confidence interval, 0.38-0.94; P=.022); and recommendation of the allocated intervention to a friend-61 per 110 (73.6%) and 87 per 110 (79.1%) (relative risk, 0.90; 95% confidence interval, 0.80-1.08; P=.341). Other secondary outcomes, including cesarean delivery, were not significantly different. CONCLUSION: Foley balloon placement for 6 hours for cervical ripening in parous women hastens birth but does not increase maternal satisfaction relative to 12-hour placement. Foley reinsertion for additional ripening was more frequent in the 6-hour group.
背景:计划在分娩诱导中放置双球囊导管 6 小时与 12 小时以加速分娩。 Foley 导管价格低廉,通常在分娩诱导中至少与专有双球囊设备一样有效。产妇对分娩诱导的满意度通常与过程的速度呈反比。
目的:本研究旨在比较 Foley 球囊放置 6 小时与 12 小时在多产妇不利宫颈成熟的分娩诱导中的作用。
研究设计:2022 年 1 月至 10 月在马来西亚一所大学医院进行了一项随机对照试验。招募了因各种原因入院接受引产的多产妇。参与者入选标准为多产(至少有 1 次既往妊娠 24 周以上的阴道分娩)、年龄≥18 岁、足月妊娠>37 周、单胎妊娠、头位、胎膜完整、正常胎儿心率图、无明显宫缩(<10 分钟内 2 次)和不利宫颈(Bishop 评分<6)。在 Foley 球囊成功插入后,将参与者随机分组,球囊放置 6 小时或 12 小时进行被动成熟,然后取出球囊检查宫颈是否适合羊膜切开术。主要结局是诱导至分娩的间隔时间和产妇对分配干预的满意度,使用视觉数字评分量表(0-10)评估。次要结局部分源自分娩诱导试验的核心结局集(妇女和新生儿健康核心结局[CROWN])。产妇结局包括干预后第一 Bishop 评分的变化、额外宫颈成熟方法的使用、球囊取出后至分娩的时间、分娩方式、剖宫产指征、催产素输注时间、分娩时出血、第三或第四度会阴撕裂、产妇感染、分娩时使用区域镇痛、住院时间、重症监护病房(ICU)入院、心肺骤停和子宫切除术的需要。次要新生儿结局包括 1 分钟和 5 分钟时的 Apgar 评分、新生儿重症监护病房(NICU)入院、脐血 pH 值、新生儿败血症、出生体重、出生创伤、缺氧缺血性脑病或需要治疗性低温治疗。分析采用 t 检验、Mann-Whitney U 检验、卡方检验和 Fisher 确切检验,视情况而定。
结果:共有 220 名女性被随机分组(每组 110 名)。关于 2 个主要结局,诱导至分娩的间隔时间中位数(四分位距)分别为 15.9(12.0-24.0)和 21.6(17.3-26.0)小时(P<.001),产妇满意度评分分别为 6(6-8)和 7(6-8)(P=.734),6 小时和 12 小时放置。分别观察到以下比率:连续使用额外的宫颈成熟剂(Foley 再插入)-29/110(26.4%)和 13/110(11.8%)(相对风险,2.23;95%置信区间,1.23-4.10;P<.001);自发性球囊排出-22/110(20.0%)和 37/110(33.6%)(相对风险,0.60;95%置信区间,0.38-0.94;P=.022);向朋友推荐分配的干预措施-61/110(73.6%)和 87/110(79.1%)(相对风险,0.90;95%置信区间,0.80-1.08;P=.341)。其他次要结局,包括剖宫产,无显著差异。
结论: Foley 球囊放置 6 小时用于多产妇宫颈成熟可加速分娩,但与 12 小时放置相比,不会增加产妇满意度。在 6 小时组中,更频繁地进行 Foley 再插入以进行额外的成熟。
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