胎膜破裂后使用福乐导尿管联合缩宫素与单纯使用缩宫素引产的随机对照试验

Foley Plus Oxytocin Compared With Oxytocin for Induction After Membrane Rupture: A Randomized Controlled Trial.

作者信息

Mackeen A Dhanya, Durie Danielle E, Lin Monique, Huls Christopher K, Qureshey Emma, Paglia Michael J, Sun Haiyan, Sciscione Anthony

机构信息

Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine and Biostatistics Core, Geisinger, Danville, Pennsylvania; the Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Lehigh Valley Health Network, Allentown, Pennsylvania; the University of Colorado School of Medicine, Aurora, Colorado; the University of Arizona College of Medicine, Phoenix at Banner University Medical Center, Phoenix, Arizona; and Christiana Care Health System, Newark, Delaware.

出版信息

Obstet Gynecol. 2018 Jan;131(1):4-11. doi: 10.1097/AOG.0000000000002374.

DOI:10.1097/AOG.0000000000002374

PMID:29215519

Abstract

OBJECTIVE

To evaluate the use of a transcervical Foley catheter plus oxytocin infusion compared with oxytocin infusion alone for labor induction and cervical ripening in women 34 weeks of gestation or greater with prelabor rupture of membranes.

METHODS

This is a randomized, multicenter trial of women with a live, singleton gestation at 34 weeks of gestation or greater with prelabor rupture of membranes, an unfavorable cervical examination (less than or equal to 2 cm dilated and less than or equal to 80% effaced), and no contraindication to labor. Participants were randomly allocated to a transcervical Foley catheter inflated to 30 cc with concurrent oxytocin infusion or oxytocin infusion alone. Oxytocin administration was standardized across sites. The primary study outcome was interval from induction to delivery. To detect a 2.5-hour difference in the interval from induction to delivery, we required outcome data on 194 women, assuming 80% power and a two-tailed α of 5%. Analysis was by intent to treat.

RESULTS

We enrolled 201 women: 93 were allocated to Foley and 108 to oxytocin. Demographics were similar between the groups. Time to delivery was not significantly different between groups: in the Foley group, it was 13.9 hours (±6.9 SD) compared with 14.4 hours (±7.9 SD) in the oxytocin group (P=.69). There were more cases of clinical chorioamnionitis (8% compared with 0%, P<.01) in the Foley group compared with the oxytocin group. There were no differences for other infectious morbidities or any other variable studied.

CONCLUSION

In patients with prelabor rupture of membranes, the use of a transcervical Foley catheter in addition to oxytocin does not shorten the time to delivery compared with oxytocin alone, but may increase the incidence of intraamniotic infection.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, NCT01973036.

摘要

目的

评估经宫颈放置 Foley 导管联合缩宫素输注与单纯缩宫素输注相比，用于妊娠 34 周及以上胎膜早破孕妇引产及促宫颈成熟的效果。

方法

这是一项随机、多中心试验，研究对象为妊娠 34 周及以上、单胎活产、胎膜早破、宫颈检查评分不佳（宫口扩张≤2cm 且宫颈管消退≤80%）且无引产禁忌证的孕妇。参与者被随机分配至经宫颈放置充有 30cc 液体的 Foley 导管并同时输注缩宫素组或单纯缩宫素输注组。各研究点缩宫素的给药方式标准化。主要研究结局为引产至分娩的间隔时间。为检测出引产至分娩间隔时间有 2.5 小时的差异，假设检验效能为 80%，双侧α为 5%，我们需要 194 名女性的结局数据。分析采用意向性分析。

结果

我们纳入了 201 名女性：93 名被分配至 Foley 导管组，108 名被分配至缩宫素组。两组的人口统计学特征相似。两组间分娩时间无显著差异：Foley 导管组为 13.9 小时（标准差±6.9），缩宫素组为 14.4 小时（标准差±7.9）（P = 0.69）。与缩宫素组相比，Foley 导管组临床绒毛膜羊膜炎病例更多（8% 对比 0%，P < 0.01）。其他感染性疾病或所研究的任何其他变量均无差异。