Cervical Ripening: A Comparison Between Intravaginal Misoprostol Tablet and Intracervical Foley's Catheter and Subsequent Induction of Labor, Safety and Efficacy in Federal Teaching Hospital Abakaliki, Ebonyi State, Nigeria.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Bishop Score of 6 or more
研究概览
简要总结
The aim of this study is to compare the effectiveness and safety of Foley's catheter and misoprostol in cervical ripening.
详细描述
This is a randomized clinical study which will be made up of two arms or groups. The first arm or group - 1 will have cervical ripening with intracervical extraamniotic Foley's catheter while group - 2 will have cervical ripening with intravaginal misoprostol. The parturients will be randomly selected by simple lottery and recruited into the two arms of the study. Each parturient will pick by simple lucky dip from a pool of folded papers with inscription group 1 or group 2 in a bag in a double blinded manner and will be recruited into the group picked among the two arms of the study. The Bishop's score of the cervix will be accurately determined and documented before cervical ripening. Bishop's score of ≥6 will be considered ripe. Oxytocin will be used for induction or augmentation of labor as required.
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
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Parturients who gave consent
- •has low bishop score (≤5)
- •term singleton cephalic presenting fetus
- •intact membranes
- •no contraindication to vaginal delivery
排除标准
- •those who refused consent
- •preterm delivery
- •vaginal infection
- •non-cephalic presentation
- •multiple gestation
- •low lying placenta/previa,
- •vaginal bleeding,
- •previous cesarean section
- •rupture of membranes
研究组 & 干预措施
group - 1 Foley's Catheter
will have cervical ripening with intracervical extraamniotic Foley's catheter for 24 hours
干预措施: Foley's Catheter (Device)
Group - 2 Prostaglandin E1 Analogue
will have cervical ripening with intravaginal misoprostol inserted into the posterior fornix every six hours to a maximum of four doses (24 hours)
干预措施: prostaglandin E1 analogue (Drug)
结局指标
主要结局
Bishop Score of 6 or more
时间窗: 24 hours
次要结局
未报告次要终点
研究者
Nwali Matthew Igwe
Dr
Federal Teaching Hospital Abakaliki