Cervical Ripening in Obese Women: a Prospective, Randomized Trial Comparing Efficacy of 25 mcg Versus 50 mcg of Misoprostol
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- Vaginal delivery
研究概览
简要总结
This is a prospective clinical trial to determine if 50 mcg versus 25 mcg po every four hours of misoprostol has improved efficacy and similar safety in obese women undergoing cesarean section.
详细描述
We will perform a prospective, randomized, double-blind clinical trial with parallel assignment.
Obese women (delivery BMI 30 or more) who agree to participation will be randomly designated to receive either 25 mcg po q 4 hour (control) misoprosol versus 50 mcg po q 4 hours. Our primary outcome will be the rate of successful induction. Secondary outcomes will include ability to achieve a Bishop score greater than 7, time to active labor, and safety data including rate of tachysystole, non-reassuring fetal status, NICU admission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Both arms will receive identical appearing drug made by the Investigational Drug Unit of the Pharmacy.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Labor induction, BMI of 30 or greater, English speaking
排除标准
- •Prior cesarean section, uterine tachysystole (5 contractions/ 10 minutes) on admission, Contraindication to labor induction
研究组 & 干预措施
Control
Standard of care, misoprostol 25 mcg po every four hours
干预措施: Misoprostol (Drug)
Intervention
Misoprostol 50 mcg po every four hours
干预措施: Misoprostol (Drug)
结局指标
主要结局
Vaginal delivery
时间窗: Variable, but within 4 days
Successful induction defined as a vaginal delivery following labor induction.
次要结局
- Completed cervical ripening(2 days)
- Rate of tachysystole, fetal nonreassuring status, uterine rupture(3 days)
- Specific time interval from start of induction to active labor(2 days)
研究者
Carri Warshak
Associate Clinical Professor
University of Cincinnati