Role of Vaginal Misoprostol Prior to IUCD Insertion in Women Who Delivered Only by Elective Caesarean Section.
试验速览
- 阶段
- 2 期
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- the proportion of failed IUCD insertions regardless of the reason .
研究概览
简要总结
Role of vaginal misoprostol prior to IUCD insertion in women who delivered only by elective caesarean section.
详细描述
Misoprostol ( 400mcg ) vaginally administrated 3 hours prior to IUCD insertion increases the ease and success of insertion and decrease associated pain among women who had delivered only by elective caesarean section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All women will be 20 to 40 years of age.
- •Desires IUCD placement and able to participate.
- •Negative pregnancy test.
- •Willing to follow- up in 6-8 weeks for a standard IUCD follow-up visit.
- •Delivered only by cesarean section.
排除标准
- •Active cervical infection.
- •Current pregnancy.
- •Uterine anomaly.
- •Fibroid uterus.
- •Copper allergy/Wilson's disease.
- •Undiagnosed abnormal uterine bleeding.
- •Cervical or uterine cancer.
- •Allergy to misoprostol.
- •Previous vaginal delivery.
研究组 & 干预措施
placebo group
2 tablets vaginally
干预措施: Placebo (Drug)
misoprostol group
400 mcg vaginally
干预措施: misoprostol (Drug)
结局指标
主要结局
the proportion of failed IUCD insertions regardless of the reason .
时间窗: during insertion
pain reported by particiepant during insertion graded from 1 to 10 on visual analogue scale
the degree of difficulty of the IUCD insertion .
时间窗: during insertion
Judged as the resistance of the internal cervical os experienced by the investigator and measured by a 5-point scale.
次要结局
- heavy bleeding(7 days)
- partial or total expulsion(4 to 6 weeks)
研究者
Enas Mahmoud Mohammed Mohammed Elshahed
MBBCh.
Ain Shams University