Foley 导管联合控释前列腺素 E2 与 Foley 导管在初产妇引产中的随机对照试验
Foley catheter and controlled release dinoprostone versus foley catheter labor induction in nulliparas: a randomized trial.
机构信息
Department of Obstetrics and Gynecology, Faculty of Medicine, University of Malaya, Jalan Profesor Diraja Ungku Aziz, 50603, Kuala Lumpur, Malaysia.
出版信息
Arch Gynecol Obstet. 2022 Oct;306(4):1027-1036. doi: 10.1007/s00404-021-06383-2. Epub 2022 Jan 9.
PURPOSE
To evaluate Foley catheter and controlled release dinoprostone insert compared to foley catheter alone on induction to delivery interval and maternal satisfaction.
METHODS
A randomized trial was conducted in a university hospital in Malaysia from December 2018 to May 2019. Term nulliparas with unfavorable cervix (Bishop score ≤ 5) scheduled for labor induction were randomized to Foley catheter and controlled release dinoprostone insert simultaneously or Foley catheter alone. Primary outcomes were induction to delivery interval (hours) and maternal satisfaction on birth experience (assessed by 11-point Visual Numerical Rating Scale VNRS 0-10, higher score more satisfied).
RESULTS
Induction to vaginal delivery intervals was mean ± standard deviation 22.5 ± 10.4 vs. 35.1 ± 14.9 h, P = < 0.001 but maternal satisfaction on birth experience was not significantly different median[interquartile range] VNRS 8[7-9] vs. 8[7-9], P = 0.12 for Foley catheter-controlled-release dinoprostone and Foley catheter alone arms, respectively. Cesarean delivery rates were 35/102(34.3%) vs. 50/101(49.5%), P = 0.02 RR 0.7 95% CI 0.5-0.9 NNTb 6.3 95% CI 3.5-39.4, pain score at 6 h after catheter insertion 5[2-8] vs. 1[1-3], P < 0.001, Bishop score at trial devices removal 9[9-10] vs. 8[7-9], P = 0.001, requirement for oxytocin induction or augmentation 39/102(38.2%) vs. 76/101(75.2%) NNTb 3 95% CI 2.0-4.1, P < 0.001 and amniotomy rates 73/99(73.7%) vs. 81/95(85.3%), P = 0.052 RR 0.9 85% CI 0.8-1.0 in Foley catheter-controlled-release dinoprostone and Foley catheter alone arms respectively.
CONCLUSION
In nulliparas with unripe cervixes at term, combined Foley catheter and controlled release dinoprostone vaginal insert compared to Foley catheter alone reduces the induction to vaginal delivery interval and cesarean delivery rate but satisfaction was not significantly increased.
CLINICAL TRIAL REGISTRATION
ISRCTN2282883, 03/12/2018, "prospectively registered" ( https://doi.org/10.1186/ISRCTN12282883 ).
目的
比较 Foley 导管联合控释前列腺素栓剂与单纯 Foley 导管在引产至分娩间隔和产妇满意度方面的效果。
方法
这是一项在马来西亚一所大学医院进行的随机试验，时间为 2018 年 12 月至 2019 年 5 月。选择有不利宫颈（Bishop 评分≤5）的足月初产妇，随机分为 Foley 导管联合控释前列腺素栓剂组或单纯 Foley 导管组。主要结局是引产至分娩的时间（小时）和产妇对分娩经历的满意度（采用 11 点视觉数字评分量表 VNRS 0-10 评估，得分越高表示满意度越高）。
结果
引产至阴道分娩的时间平均（±标准差）分别为 22.5（±10.4）小时和 35.1（±14.9）小时，P<0.001，但产妇对分娩经历的满意度差异无统计学意义（中位数[四分位间距]）分别为 Foley 导管联合控释前列腺素栓剂组 8（7-9）分和 Foley 导管组 8（7-9）分，P=0.12。剖宫产率分别为 35/102（34.3%）和 50/101（49.5%），P=0.02（RR 0.7，95%CI 0.5-0.9；NNTb 6.3，95%CI 3.5-39.4），导管插入后 6 小时疼痛评分分别为 5（2-8）分和 1（1-3）分，P<0.001，试验器械去除时的 Bishop 评分分别为 9（9-10）分和 8（7-9）分，P=0.001，催产素诱导或增强的需求分别为 39/102（38.2%）和 76/101（75.2%），NNTb 3，95%CI 2.0-4.1，P<0.001，羊膜切开率分别为 73/99（73.7%）和 81/95（85.3%），P=0.052（RR 0.9，85%CI 0.8-1.0）。
结论
在足月有未成熟宫颈的初产妇中，与单纯 Foley 导管相比，Foley 导管联合控释前列腺素栓剂阴道插入可缩短引产至阴道分娩的时间和剖宫产率，但满意度无显著增加。
临床试验注册
ISRCTN2282883，2018 年 12 月 3 日，“前瞻性注册”（https://doi.org/10.1186/ISRCTN12282883）。
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