Comparison of outcome of labor induction by combination of Foleys catheter with either titrated oral misoprostol solution or sublingual misoprostol among nulliparous women at term - A randomized controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Proportion of successful vaginal delivery
研究概览
简要总结
This is a randomised controlled trial to compare the outcome of induction of labor by intracervical Foley’s catheter with titrated oral misoprostol solution versus intracervical Foley’s catheter with sublingual misoprostol in nulliparous women at term. this study will be conducted for 18 months in a tertiary centre in South India. 152 women in one group will receive titrated misoprostol solution after insertion of intracervical Foley’s catheter, while 152 women in the other group will receive sublingual misoprostol after insertion of intracervical Foley’s catheter. The primary outcome is measured by the proportion of successful vaginal deliveries. the secondary outcomes observed will be the difference in the time from induction to delivery and incidence of any maternal or fetal adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Nulliparous women ≥ 18 years of age 2)Gestational age ≥ 37 weeks 3)Singleton pregnancy, vertex presentation 4)Bishop’s score less than or equal to 4.
排除标准
- •Women with severe pre-eclampsia 2)Premature rupture of membranes 3)Previously scarred uterus (myomectomy/ septal resection) 4)Previous anaphylaxis to prostaglandins 5)Abnormal FHR changes.
结局指标
主要结局
Proportion of successful vaginal delivery
时间窗: 72 hours after insertion of foleys catheter
次要结局
- Maternal & fetal outcome(72 hours after insertion of foleys catheter)
- Time from induction to delivery(72 hours after insertion of foleys catheter)
研究者
Lakshanya
Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry