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多产妇未成熟宫颈行 Foley 导管引产:门诊与住院患者的随机试验。

Outpatient vs inpatient Foley catheter induction of labor in multiparas with unripe cervixes: A randomized trial.

机构信息

Department of Obstetrics and Gynecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.

出版信息

Acta Obstet Gynecol Scand. 2021 Nov;100(11):1977-1985. doi: 10.1111/aogs.14247. Epub 2021 Aug 30.

DOI:10.1111/aogs.14247
PMID:34462906
Abstract

INTRODUCTION

Multiparous labor inductions are typically successful, and the process can be rapid, starting from a ripened cervix with a predictable response to amniotomy and oxytocin infusion. Outpatient Foley catheter labor induction in multiparas with unripe cervixes is a feasible option as the mechanical process of ripening is usually without significant uterine contractions and well tolerated. Labor contractions can be initiated by amniotomy and titrated oxytocin infusion in the hospital for well-timed births during working hours as night birth are associated with adverse events. We sought to evaluate outpatient compared with inpatient Foley catheter induction of labor in multiparas for births during working hours and maternal satisfaction.

MATERIAL AND METHODS

A randomized trial was conducted in the University of Malaya Medical Center. A total of 163 term multiparas (no dropouts) with unripe cervixes (Bishop score ≤5) scheduled for labor induction were randomized to outpatient or inpatient Foley catheter. Primary outcomes were delivery during "working hours" 08:00-18:00 h and maternal satisfaction on allocated care (assessed by 11-point visual numerical rating score 0-10, with higher score indicating more satisfied).

CLINICAL TRIAL REGISTRATION

ISRCTN13534944.

RESULTS

Comparing outpatient and inpatient arms, delivery during working hours were 54/82 (65.9%) vs. 48/81 (59.3%) (relative risk 1.1, 95% CI 0.9-1.4, p = 0.421) and median maternal satisfaction visual numerical rating score was 9 (interquartile range 9-9) vs. 9 (interquartile range 8-9, p = 0.134), repectively. Duration of hospital stay and membrane rupture to delivery interval were significantly shorter in the outpatient arm: 35.8 ± 20.2 vs. 45.2 ± 16.2 h (p = 0.001) and 4.1 ± 2.9 vs. 5.3 ± 3.6 h (p = 0.020), respectively. Other maternal and neonatal secondary outcomes were not significantly different.

CONCLUSIONS

The trial failed to demonstrate the anticipated increase in births during working hours with outpatient compared with inpatient induction of labor with Foley catheter in parous women with an unripe cervix. Hospital stay and membrane rupture to delivery interval were significantly shortened in the outpatient group. The rate of maternal satisfaction was high in both groups and no significant differences were found.

摘要

简介

多产妇的引产通常是成功的,而且过程可以很快,从成熟的宫颈开始,对羊膜穿刺术和催产素输注有可预测的反应。对于宫颈不成熟的多产妇,门诊 Foley 导管引产是一种可行的选择,因为成熟的机械过程通常没有明显的子宫收缩,并且可以很好地耐受。可以通过羊膜穿刺术和滴定催产素输注来启动分娩宫缩,以便在工作时间内进行适时分娩,因为夜间分娩与不良事件有关。我们旨在评估门诊与住院 Foley 导管引产在多产妇中的效果,以观察其在工作时间内分娩的情况和产妇满意度。

材料和方法

该研究在马来西亚大学医学中心进行了一项随机试验。共有 163 名足月多产妇(无脱落),宫颈不成熟(Bishop 评分≤5),计划引产,随机分为门诊或住院 Foley 导管组。主要结局是在 08:00-18:00 期间分娩(“工作时间”)和产妇对分配护理的满意度(通过 11 点视觉数字评分 0-10 进行评估,得分越高表示越满意)。

临床试验注册

ISRCTN83324102。

结果

与住院组相比,门诊组在工作时间分娩的产妇分别为 54/82(65.9%)和 48/81(59.3%)(相对风险 1.1,95%CI 0.9-1.4,p=0.421),产妇满意度视觉数字评分中位数分别为 9(四分位距 9-9)和 9(四分位距 8-9,p=0.134)。门诊组的住院时间和胎膜破裂至分娩的时间间隔明显更短:35.8±20.2 小时与 45.2±16.2 小时(p=0.001)和 4.1±2.9 小时与 5.3±3.6 小时(p=0.020)。其他产妇和新生儿的次要结局没有显著差异。

结论

与住院 Foley 导管引产相比,门诊 Foley 导管引产不能预期增加多产妇在工作时间内分娩,且对于宫颈不成熟的多产妇,门诊组的住院时间和胎膜破裂至分娩的时间间隔明显缩短。两组产妇的满意度均较高,且无显著差异。

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