OBJECTIVE: 

To assess whether outpatient cervical ripening with a synthetic osmotic dilator shortens the length of hospital stay in term pregnancies undergoing labor induction.

METHODS: 

Pregnant participants scheduled for labor induction at term with unfavorable cervix (less than 3-cm dilated and less than 60% effaced) and not requiring inpatient maternal or fetal monitoring were consented, and synthetic osmotic dilator rods were inserted on the day of scheduled induction. After reassuring fetal heart tracing, patients randomized to the outpatient group were asked to return 12 hours after insertion or sooner if needed. Those randomized to the inpatient group remained in the hospital. After the first round of ripening, additional ripening, oxytocin, and labor management were left up to the clinical health care professionals. The primary outcome was the proportion of participants with hospital stays longer than 48 hours. We estimated that a sample size of 338 would provide 85% power to detect a 30% difference between groups.

RESULTS: 

From November 2018 to November 2021, 339 participants were randomized (171 inpatient, 167 outpatient, one withdrawal). Four patients in the outpatient group were admitted before12 hours for suspected labor and rupture of membranes, and 19 in the inpatient group had the device removed before 12 hours. The proportion of participants with hospital stays longer than 48 hours was lower in the outpatient group compared with the inpatient group (89 [53%] vs 152 [89%], relative risk [RR] 0.60, 95% CI 0.52–0.70). Patients in the outpatient group had a shorter total length of stay and time from admission to active labor. They were more likely to have a vaginal delivery within 24 hours of admission and were less likely to receive analgesics during ripening. Route of delivery and other maternal and neonatal outcomes were not significantly different between groups.

CONCLUSION: 

Outpatient cervical ripening with a cervical osmotic dilator decreased hospital stay compared with inpatient ripening, without significant adverse outcomes.

FUNDING SOURCE: 

Medicem Technology s.r.o., Czech Republic.

CLINICAL TRIAL REGISTRATION: 

ClinicalTrials.gov, NCT03665688.

中文翻译：

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门诊患者与使用合成渗透扩张器的住院患者诱导前宫颈成熟比较：一项随机临床试验

客观的： 

评估使用合成渗透扩张器的门诊宫颈成熟是否会缩短接受引产的足月妊娠的住院时间。

方法： 

计划在足月进行引产且宫颈不良（扩张小于 3 cm 且小于 60%）且不需要住院母体或胎儿监测的妊娠参与者得到同意，并在计划引产当天插入合成渗透扩张棒。在确定胎儿心脏追踪后，随机分配到门诊组的患者被要求在插入后 12 小时或更早（如果需要）返回。那些被随机分配到住院组的人仍然留在医院。在第一轮催熟之后，额外催熟、催产和分娩管理留给临床医疗保健专业人员。主要结果是住院时间超过 48 小时的参与者比例。我们估计 338 个样本大小将提供 85% 的功效来检测组间 30% 的差异。

结果： 

从 2018 年 11 月到 2021 年 11 月，339 名参与者被随机分配（171 名住院患者，167 名门诊患者，1 名停药）。门诊组 4 例患者在 12 小时前因疑似分娩和胎膜破裂入院，住院组 19 例患者在 12 小时前取出装置。与住院组相比，门诊组住院时间超过 48 小时的参与者比例较低（89 [53%] vs 152 [89%]，相对风险 [RR] 0.60，95% CI 0.52–0.70）。门诊组患者的总住院时间和从入院到积极分娩的时间较短。他们更有可能在入院后 24 小时内进行阴道分娩，并且在成熟期间不太可能接受镇痛剂。

结论： 

与住院催熟相比，使用宫颈渗透扩张器的门诊宫颈催熟减少了住院时间，没有明显的不良后果。

资金来源： 

捷克共和国Medicem Technology sro。

临床试验注册： 

ClinicalTrials.gov，NCT03665688。