Abstract：
BACKGROUND: Foley catheter insertion is frequently used for cervical ripening during the induction of labor. However, the insertion failure, safety, maternal side effects, complications, and satisfaction of digital compared with speculum-guided Foley catheter placement have not been evaluated in a large trial involving primigravida.
OBJECTIVE: The study aimed to compare the insertion failure rate of digital and speculum-based transcervical Foley catheter placement in primigravida. The co-primary outcome was insertion-associated pain. The secondary outcomes were the time required for successful insertion, maternal satisfaction, and maternal complications within 24 hours of Foley insertion.
METHODS: This randomized, open-label, parallel-arm, noninferiority clinical trial was performed in a large tertiary care university hospital. Primigravida aged >18 years with term gestation (≥37 weeks) were included in this study. Additional inclusion criteria for enrollment in this study were singleton pregnancy with a cephalic presentation, intact membrane, a Bishop score of ≤5, and reassuring preinduction fetal heart rate tracing. All women planned for cervical ripening were assessed for eligibility and were randomized into digital or speculum arms. Foley catheter insertion was performed in a supine lithotomy position. Vaginal and cervical cleaning were performed before insertion. A 22-French Foley balloon catheter was guided digitally or via speculum to position the bulb at the level of the internal os using water-soluble lubricant. Insertion-associated pain was measured using a visual numeric rating scale, and maternal satisfaction was assessed using a set of questions.
RESULTS: Four hundred and sixty-nine pregnant women were assessed for eligibility, and 446 patients were enrolled and randomized. The median age of the parturients was 24 (19-40) and 24 (18-38) years, respectively. The body mass index, gestational age at randomization, the incidence of postdated pregnancy, and prerandomization Bishop scores were comparable. Insertion failure was observed in 24 (10.8%) and 17 (7.6%) women in digital and speculum arms, respectively (relative risk=1.41 [95% confidence interval, 0.78-2.55]; P=.25). Requirements of >1 attempt (5.4% vs 3.6%) followed by the change in hands (3.6% vs 2.7%) were the most common reasons for insertion failure. The median (interquartile range) visual numeric rating scale was comparable (6 [2-9] vs 5 [2-10]; P=.15). The time taken for successful insertion was similar (58 [12-241] vs 54 [10-281]; P=.30). 9.4% and 10.8% of women required additional methods of cervical ripening. More women in the speculum group (41.7% vs 33.2%; P=.06) felt a medium level of discomfort than the digital group.
CONCLUSIONS: Insertion failure and insertion-related pain in the digital approach were comparable to the speculum-guided approach for transcervical Foley catheter insertion in primigravida for cervical ripening. Nevertheless, maternal satisfaction was higher in the digital group because of a lesser level of discomfort.
OBJECTIVE: The study aimed to compare the insertion failure rate of digital and speculum-based transcervical Foley catheter placement in primigravida. The co-primary outcome was insertion-associated pain. The secondary outcomes were the time required for successful insertion, maternal satisfaction, and maternal complications within 24 hours of Foley insertion.
METHODS: This randomized, open-label, parallel-arm, noninferiority clinical trial was performed in a large tertiary care university hospital. Primigravida aged >18 years with term gestation (≥37 weeks) were included in this study. Additional inclusion criteria for enrollment in this study were singleton pregnancy with a cephalic presentation, intact membrane, a Bishop score of ≤5, and reassuring preinduction fetal heart rate tracing. All women planned for cervical ripening were assessed for eligibility and were randomized into digital or speculum arms. Foley catheter insertion was performed in a supine lithotomy position. Vaginal and cervical cleaning were performed before insertion. A 22-French Foley balloon catheter was guided digitally or via speculum to position the bulb at the level of the internal os using water-soluble lubricant. Insertion-associated pain was measured using a visual numeric rating scale, and maternal satisfaction was assessed using a set of questions.
RESULTS: Four hundred and sixty-nine pregnant women were assessed for eligibility, and 446 patients were enrolled and randomized. The median age of the parturients was 24 (19-40) and 24 (18-38) years, respectively. The body mass index, gestational age at randomization, the incidence of postdated pregnancy, and prerandomization Bishop scores were comparable. Insertion failure was observed in 24 (10.8%) and 17 (7.6%) women in digital and speculum arms, respectively (relative risk=1.41 [95% confidence interval, 0.78-2.55]; P=.25). Requirements of >1 attempt (5.4% vs 3.6%) followed by the change in hands (3.6% vs 2.7%) were the most common reasons for insertion failure. The median (interquartile range) visual numeric rating scale was comparable (6 [2-9] vs 5 [2-10]; P=.15). The time taken for successful insertion was similar (58 [12-241] vs 54 [10-281]; P=.30). 9.4% and 10.8% of women required additional methods of cervical ripening. More women in the speculum group (41.7% vs 33.2%; P=.06) felt a medium level of discomfort than the digital group.
CONCLUSIONS: Insertion failure and insertion-related pain in the digital approach were comparable to the speculum-guided approach for transcervical Foley catheter insertion in primigravida for cervical ripening. Nevertheless, maternal satisfaction was higher in the digital group because of a lesser level of discomfort.
摘要：
背景：Foley导管插入经常用于引产期间的宫颈成熟。然而,插入失败，安全,母体副作用,在一项涉及primigravida的大型试验中,尚未评估数字导管与窥器引导Foley导管置入相比的并发症和满意度.
目的：该研究旨在比较数字和基于窥器的经宫颈Foley导管在primigravida中的插入失败率。共同的主要结果是插入相关的疼痛。次要结果是成功插入所需的时间，产妇满意度,以及插入Foley后24小时内的母体并发症。
方法：这是随机的，开放标签，平行臂,非劣效性临床试验在一家大型三级护理大学医院进行.本研究包括年龄>18岁的足月妊娠（≥37周）的Primigravida。本研究的其他纳入标准是单胎妊娠伴头颅表现，完整的膜，Bishop评分≤5，并确保诱导前胎儿心率追踪。所有计划宫颈成熟的妇女都接受了资格评估，并被随机分配到数字或窥器臂中。在仰卧位进行Foley导管插入。插入前进行阴道和宫颈清洁。使用水溶性润滑剂以数字方式或通过窥器引导22-FrenchFoley球囊导管，以将灯泡定位在内部操作系统的水平。使用视觉数字评定量表（VNRS）测量插入相关疼痛，并使用一组问题评估产妇满意度。
结果：对469名孕妇进行了资格评估，446例患者被纳入并随机分组.产妇的中位年龄为24（19-40）和24（18-38）岁，分别。体重指数,随机分组时的胎龄，过期妊娠发生率和随机化前Bishop评分具有可比性.在数字臂和窥器臂中观察到24名（10.8％）和17名（7.6％）女性的插入失败，分别为(RR=1.41；95%CI，0.78-2.55；P=0.25)。需要一次以上的尝试（5.4％vs3.6％），然后换手（3.6％vs2.7％）是插入失败的最常见原因。VNRS中位数（四分位距）相当（6.00（2-9）与5.00（2-10）；p=0.15）。成功插入所需的时间相似（58（12-241）对54（10-281）；p=0.30）。9.4%和10.8%的女性需要额外的宫颈成熟方法。窥器组中更多的女性（41.7％vs33.2％；P=0.06）比数字组感到中等水平的不适。
结论：数字方法中的插入失败和插入相关疼痛与窥器引导的方法在primigravida中经宫颈Foley导管插入宫颈成熟相当。然而，由于不适程度较低,数字组产妇满意度较高.
目的：该研究旨在比较数字和基于窥器的经宫颈Foley导管在primigravida中的插入失败率。共同的主要结果是插入相关的疼痛。次要结果是成功插入所需的时间，产妇满意度,以及插入Foley后24小时内的母体并发症。
方法：这是随机的，开放标签，平行臂,非劣效性临床试验在一家大型三级护理大学医院进行.本研究包括年龄>18岁的足月妊娠（≥37周）的Primigravida。本研究的其他纳入标准是单胎妊娠伴头颅表现，完整的膜，Bishop评分≤5，并确保诱导前胎儿心率追踪。所有计划宫颈成熟的妇女都接受了资格评估，并被随机分配到数字或窥器臂中。在仰卧位进行Foley导管插入。插入前进行阴道和宫颈清洁。使用水溶性润滑剂以数字方式或通过窥器引导22-FrenchFoley球囊导管，以将灯泡定位在内部操作系统的水平。使用视觉数字评定量表（VNRS）测量插入相关疼痛，并使用一组问题评估产妇满意度。
结果：对469名孕妇进行了资格评估，446例患者被纳入并随机分组.产妇的中位年龄为24（19-40）和24（18-38）岁，分别。体重指数,随机分组时的胎龄，过期妊娠发生率和随机化前Bishop评分具有可比性.在数字臂和窥器臂中观察到24名（10.8％）和17名（7.6％）女性的插入失败，分别为(RR=1.41；95%CI，0.78-2.55；P=0.25)。需要一次以上的尝试（5.4％vs3.6％），然后换手（3.6％vs2.7％）是插入失败的最常见原因。VNRS中位数（四分位距）相当（6.00（2-9）与5.00（2-10）；p=0.15）。成功插入所需的时间相似（58（12-241）对54（10-281）；p=0.30）。9.4%和10.8%的女性需要额外的宫颈成熟方法。窥器组中更多的女性（41.7％vs33.2％；P=0.06）比数字组感到中等水平的不适。
结论：数字方法中的插入失败和插入相关疼痛与窥器引导的方法在primigravida中经宫颈Foley导管插入宫颈成熟相当。然而，由于不适程度较低,数字组产妇满意度较高.
