Jamaluddin Arifah, Azhary Jerilee Mariam Khong, Hong Jesrine Gek Shan, Hamdan Mukhri, Tan Peng Chiong
Department of Obstetrics and Gynecology, Faculty of Medicine, Universiti Malaya, Jalan Profesor Diraja Ungku Aziz, Kuala Lumpur, Malaysia.
Int J Gynaecol Obstet. 2023 Feb;160(2):661-669. doi: 10.1002/ijgo.14361. Epub 2022 Aug 8.
To evaluate immediate oxytocin and early amniotomy compared with delayed amniotomy after Foley catheter cervical ripening in multiparous women on intervention-to-delivery interval.
This randomized trial was conducted in Malaysia in 232 term multiparous women with balloon catheter-ripened cervixes (dilatation ≥3 cm), singleton fetus, cephalic presentation with intact membranes, and reassuring fetal heart rate tracing. They were randomized to immediate titrated intravenous oxytocin infusion and early amniotomy (116) or delayed amniotomy after 4 h of oxytocin (116). Primary outcome was intervention (oxytocin initiation)-to-delivery interval.
Oxytocin-to-delivery intervals were a median of 4.99 h (interquartile range [IQR], 3.21-7.82 h) versus 6.23 h (IQR, 4.50-8.45 h) (P < 0.001) for the early versus delayed amniotomy arms, respectively. Delivery rate at 4 h and 6 h after oxytocin infusion were 40 of 116 (35%) versus 22 of 116 (19%) (relative risk [RR], 1.82 [95% confidence interval (CI), 1.16-2.86], P = 0.011) and 77 of 116 (66%) versus 54 of 116 (47%) (RR, 1.43 [95% CI, 1.13-1.80], P = 0.003) for the early versus delayed amniotomy arms, respectively. Maternal satisfaction on birth process were 7 (IQR, 6-8) versus 7 (IQR, 7-8) (P = 0.006), uterine hyperstimulation rates were 10 of 116 (9%) versus 14 of 116 (12%) (RR, 0.71 [95% CI, 0.33-1.54]) (P = 0.519), and Cesarean delivery rates were 17 of 116 (15%) versus 19 of 116 (16%) (RR, 0.90 [95% CI, 0.49-1.63], P = 0.856) for the early versus delayed amniotomy arms, respectively.
In multiparas at term following cervical ripening by Foley catheter, immediate oxytocin and early amniotomy compared with a scheduled 4-h delay to amniotomy shortens the interval to birth and decreases uterine hyperactivity in labor but lowers maternal satisfaction. The cesarean delivery rate is not significantly reduced.
This study was registered with the International Standard Randomised Controlled Trial Number (ISRCTN) on September 29, 2020, with trial identification number: ISRCTN87066007 (https://doi.org/10.1186/ISRCTN87066007). The first participant was recruited on September 29, 2020, after ISRCTN registry confirmation was received.
评估在经产妇中，与Foley导管促宫颈成熟后延迟破膜相比，即刻使用缩宫素联合早期破膜对干预至分娩间隔时间的影响。
这项随机试验于马来西亚开展，纳入232名足月经产妇，她们均使用球囊导管促宫颈成熟（宫颈扩张≥3 cm），单胎妊娠，头先露，胎膜完整，胎儿心率监测结果令人放心。将她们随机分为两组，一组即刻静脉滴注缩宫素并早期破膜（116例），另一组在缩宫素使用4小时后延迟破膜（116例）。主要结局指标是干预（开始使用缩宫素）至分娩的间隔时间。
早期破膜组与延迟破膜组的缩宫素至分娩间隔时间中位数分别为4.99小时（四分位数间距[IQR]，3.21 - 7.82小时）和6.23小时（IQR，4.50 - 8.45小时）（P < 0.001）。缩宫素输注后4小时和6小时的分娩率，早期破膜组分别为116例中的40例（35%）和116例中的77例（66%），延迟破膜组分别为116例中的22例（19%）和116例中的54例（47%）（相对危险度[RR]分别为1.82 [95%置信区间(CI)，1.16 - 从1.82 [95%置信区间(CI)，1.16 - 2.86]，P = 0.011]和1.43 [95% CI，1.13 - 1.80]，P = 0.003）。产妇对分娩过程的满意度评分分别为7（IQR，6 - 8）和7（IQR，7 - 8）（P = 0.006），子宫过度刺激率分别为116例中的10例（9%）和116例中的14例（12%）（RR，0.71 [95% CI，0.33 - 1.54]）（P = 0.519），剖宫产率分别为116例中的17例（15%）和116例中的19例（16%）（RR，0.90 [95% CI，0.49 - 1.63]，P = 0.856）。
在经Foley导管促宫颈成熟的足月经产妇中，与计划延迟破膜4小时相比，即刻使用缩宫素联合早期破膜可缩短分娩间隔时间，并降低分娩时子宫过度活动，但会降低产妇满意度。剖宫产率没有显著降低。
本研究于2020年9月29日在国际标准随机对照试验编号（ISRCTN）注册，试验识别号：ISRCTN87066007（https://doi.org/10.1186/ISRCTN87066007）。在收到ISRCTN注册确认后，于2020年9月29日招募了第一名参与者。
