Foley 导管与控释地诺前列酮阴道栓剂用于一次剖宫产术后引产的比较：一项随机试验。
Foley catheter compared with controlled release dinoprostone vaginal insert for labor induction after one previous cesarean delivery: A randomized trial.
机构信息
Department of Obstetrics and Gynecology, Faculty of Medicine, Universiti Malaya, Jalan Profesor Diraja Ungku Aziz, Kuala Lumpur, Malaysia.
出版信息
Int J Gynaecol Obstet. 2023 Mar;160(3):814-822. doi: 10.1002/ijgo.14364. Epub 2022 Aug 8.
OBJECTIVE
To compare Foley catheter and controlled-release dinoprostone vaginal insert on induction-to-delivery interval and maternal satisfaction in women with one previous cesarean delivery.
METHODS
This randomized controlled trial was conducted at the University Malaya Medical Center, Kuala Lumpur, Malaysia, from December 12, 2018, to May 28, 2019. A total of 78 term women scheduled for labor induction with one previous cesarean delivery who had ripe cervixes, singleton gestation, cephalic presentation, intact membranes, and reassuring cardiotocogram were randomized to Foley catheter or dinoprostone insert. The primary outcome was induction-to-delivery interval (in hours) and the secondary outcomes included maternal satisfaction on birth experience (assessed by 100-mm visual analog scale).
RESULTS
Induction-to-delivery intervals were as follows: median 33.5 h (interquartile range [IQR], 26.1-36.2 h) versus 23.5 h (IQR, 12.7-34.5 h) (P = 0.004), and maternal satisfaction on birth process 100-mm visual analog scale was 80 mm (IQR, 64-88 mm) versus 82 mm (IQR, 67-88 mm) (P = 0.919) for the Foley and controlled-release dinoprostone arms, respectively. Cesarean delivery rates were 23 of 39 (59%) versus 20 of 39 (51%) (relative risk, 1.15 [95% confidence interval, 0.77-1.72]) (P = 0.496) and trial device insertion to removal time mean ± standard deviation was 20.1 ± 7.1 h versus 14.2 ± 7.3 h (P = 0.001) for Foley versus controlled-release dinoprostone, respectively.
CONCLUSION
In term women after one previous cesarean delivery with unripe cervixes, controlled-release dinoprostone vaginal insert compared with Foley catheter shortens the induction-to-delivery interval but maternal satisfaction was not significantly increased.
CLINICAL TRIAL REGISTRATION
This study was registered with ISRCTN on November 30, 2018, with trial identification number: ISRCTN16957529 (https://doi.org/10.1186/ISRCTN16957529). The first participant was recruited on December 12, 2018.
目的
比较 Foley 导管和控释地诺前列酮阴道栓剂在有一次剖宫产史的产妇中的引产至分娩间隔和产妇满意度。
方法
本随机对照试验于 2018 年 12 月 12 日至 2019 年 5 月 28 日在马来西亚吉隆坡马来亚大学医学中心进行。共有 78 名足月、有一次剖宫产史、宫颈成熟、单胎妊娠、头位、胎膜完整且胎心监护正常的产妇随机分为 Foley 导管组或地诺前列酮栓剂组。主要结局为引产至分娩的时间间隔（小时），次要结局包括产妇对分娩过程的满意度（100mm 视觉模拟量表评估）。
结果
引产至分娩的时间间隔分别为：中位数 33.5 小时（IQR，26.1-36.2 小时）与 23.5 小时（IQR，12.7-34.5 小时）（P=0.004），Foley 组和控释地诺前列酮组产妇对分娩过程的满意度分别为 100mm 视觉模拟量表 80mm（IQR，64-88mm）与 82mm（IQR，67-88mm）（P=0.919）。剖宫产率分别为 Foley 组 23 例（59%）与控释地诺前列酮组 20 例（51%）（相对风险，1.15[95%置信区间，0.77-1.72]）（P=0.496），Foley 组与控释地诺前列酮组试验装置插入至取出的平均时间分别为 20.1±7.1 小时与 14.2±7.3 小时（P=0.001）。
结论
在有一次剖宫产史且宫颈不成熟的足月产妇中，与 Foley 导管相比，控释地诺前列酮阴道栓剂可缩短引产至分娩的时间间隔，但产妇满意度无显著增加。
临床试验注册
本研究于 2018 年 11 月 30 日在 ISRCTN 注册，试验识别号为 ISRCTN16957529（https://doi.org/10.1186/ISRCTN16957529）。第一名参与者于 2018 年 12 月 12 日入组。
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