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临床试验/NCT03796416
NCT03796416撤回不适用

Obesity Study to Assess Induction of Labor With Balloon and Cytotec: a Randomized Control Trial

University of Maryland, Baltimore0 个研究点开始时间: 2019年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
主要终点
achieving complete cervical dilation

研究概览

简要总结

There are more and more pregnant women who are obese. It is very difficult for obese women to get into labor. That is why when women are obese, half are likely to need a Cesarean delivery(C-section). Unfortunately, C-sections are more dangerous for obese women. There may be a combination of issues that cause obese women to need C-sections. We believe one of those reasons is that the womb of obese women respond differently to medications and devices compared to non-obese women. There are commonly two ways to help women get into labor. One way is a medication called misoprostol. The second way is a device called Foley balloon. In most studies, both ways are equally effective in helping women get into labor. However, these studies included everyone, and didn't focus on obese women.

So far there are no studies in this area that focus only on obese women. Therefore we need to design this study to focus just on obese women and what is the best way to help them get into labor and avoid a C-section.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Morbidly obese patient (BMI≥40kg/m2) at admission for induction of labor Speaks English Gestational age between 37and0 weeks and 41and6 weeks Cervical exam: dilation <4cm and Bishop score 6 or less Contractions < 2 per 10 minutes

排除标准

  • History of cesarean delivery Maternal contraindications to labor Fetal contraindications to labor Maternal age <18yo Fetal growth restriction with abnormal umbilical artery Doppler indexes Cervical dilation ≥4cm or Bishop score ≥7 Contractions ≥3 per 10 minutes Non-reassuring fetal status Latex allergy

研究组 & 干预措施

misoprostol

Active Comparator

Induction using misoprostol:

Insert misoprostol 25 micrograms in the posterior fornix of the vagina digitally Repeat cervical exam every 4 hours

干预措施: Misoprostol (Drug)

Misoprostol and foley bulb

Experimental

Induction using Foley balloon combined with misoprostol:

A 26 French intracervical Foley balloon will be inserted above the internal os at the start of induction, inflated using 80cc of sterile water.

If a Foley balloon is not able to be inserted at the time of starting induction of labor, misoprostol 25microgram can be inserted in the posterior fornix of the vagina and the misoprostol protocol followed.

干预措施: Misoprostol (Drug)

结局指标

主要结局

achieving complete cervical dilation

时间窗: 24 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Crimmins

Assistant Professor

University of Maryland, Baltimore

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Obesity Study to Assess Induction of Labor | 临床试验