Outpatient balloon catheter versus expectant management for post-term labor induction in nulliparous women: A randomized trial

IF 1.7 4区医学 Q3 OBSTETRICS & GYNECOLOGY Journal of gynecology obstetrics and human reproduction Pub Date : 2024-07-10 DOI:10.1016/j.jogoh.2024.102822

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Abstract

Background

Increased use of labor induction has renewed interest in outpatient cervical ripening. Post-term pregnancy (i.e., ≥41 weeks) is a specific situation of increased neonatal risk, including greater risk of perinatal death and adverse perinatal outcomes. While a high proportion of these patients will need induction, outpatient management of this specific population has never been studied. Therefore, our objective was to compare two policies of management of post term pregnancies: the use of a transcervical Foley catheter for outpatient cervical ripening compared with expectant management.

Methods

Multicenter, randomized controlled open-label study comparing home induction with a Foley catheter versus expectant management. Inclusion criteria were nulliparous, live singleton fetus in a vertex position, post-term (at 41 + 4 days), requiring cervical ripening (Bishop score <6), intact membranes, and distance home-hospital within 40 min. The primary endpoint was change in Bishop score beetween randomization (41 + 4 days) and consultation (41 + 5 days).

Results

Forty-five women were included: 21 in the home induction group and 24 in the control group. The study was stopped due to low recruitment. The difference in Bishop score increases one day after randomization approached significance (p = 0.055), with home induction showing a larger change compared with expectant management (Cohen's d = 0.60; 95 % confidence interval [CI] −0.002 to 1.21). Regarding change in Bishop score, 81 % of home induction group patients had a better score at 41 + 5 days versus 52.2 % in the control group (relative risk = 1.55; 95 %CI 0.99 to 2.15).

Conclusion

By specifically evaluating home induction in nulliparous women with post term pregnancies, we observed a Bishop score improvement in the home induction group. These data support further evaluation of induction methods and birth experiences in a larger cohort of this population.

Trial registration

The study was registered under European policy (number EudraCT 2015-A01298–41) and on www.clinitrials.gov (number NCT02932319). Date of registration: 13/10/2016, Date of initial participant enrollment: 31/03/2017

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门诊球囊导管与期待疗法在无阴道妇女产后引产中的对比：随机试验。

背景：-引产的使用率越来越高，使人们对门诊宫颈成熟术重新产生了兴趣。过期妊娠（即≥41周）是新生儿风险增加的一种特殊情况，包括围产期死亡和围产期不良结局的风险增加。虽然这些患者中有很大一部分需要引产，但对这一特殊人群的门诊管理却从未进行过研究。因此，我们的目标是比较两种处理过期妊娠的政策：使用经宫颈的 Foley 导管进行门诊宫颈成熟术与期待疗法。纳入标准为无阴道、活产单胎、头位、足月（41+4 天）、需要宫颈成熟（Bishop 评分小于 6 分）、胎膜完整、从家到医院的距离不超过 40 分钟。主要终点是随机分组（41 + 4 天）和会诊（41 + 5 天）之间 Bishop 评分的变化：- 结果：共纳入 45 名妇女：结果：共纳入 45 名妇女：家庭引产组 21 人，对照组 24 人。研究因招募人数较少而停止。随机分组一天后，Bishop 评分的增加差异接近显著性（p = 0.055），与预期管理相比，居家引产的变化更大（Cohen's d = 0.60；95% 置信区间 [CI] -0.002 至 1.21）。关于 Bishop 评分的变化，81% 的居家引产组患者在 41+5 天时的 Bishop 评分有所提高，而对照组为 52.2%（相对风险 = 1.55；95%CI 0.99 至 2.15）。这些数据支持在更大的人群中进一步评估引产方法和分娩经验：该研究根据欧洲政策注册（编号为EudraCT 2015-A01298-41），并在www.clinitrials.gov（编号为NCT02932319）。注册日期注册日期：2016年10月13日，初始参与者注册日期：2017年3月31日：31/03/2017.

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来源期刊

Journal of gynecology obstetrics and human reproduction Medicine-Obstetrics and Gynecology

CiteScore

3.70

自引率

5.30%

发文量

210

审稿时长

31 days

期刊介绍： Formerly known as Journal de Gynécologie Obstétrique et Biologie de la Reproduction, Journal of Gynecology Obstetrics and Human Reproduction is the official Academic publication of the French College of Obstetricians and Gynecologists (Collège National des Gynécologues et Obstétriciens Français / CNGOF). J Gynecol Obstet Hum Reprod publishes monthly, in English, research papers and techniques in the fields of Gynecology, Obstetrics, Neonatology and Human Reproduction: (guest) editorials, original articles, reviews, updates, technical notes, case reports, letters to the editor and guidelines. Original works include clinical or laboratory investigations and clinical or equipment reports. Reviews include narrative reviews, systematic reviews and meta-analyses.

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