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临床试验/NCT02574338
NCT02574338已完成不适用

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.

Nwali Matthew Igwe1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
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

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

Active Comparator

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

Active Comparator

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

发起方
Nwali Matthew Igwe
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Nwali Matthew Igwe

Dr

Federal Teaching Hospital Abakaliki

研究点 (1)

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