SUB LINGUAL MISOPROSTOL PRIOR TO IUD INSERTION IN WOMEN WITH ONLY PREVIOUS CESARIAN SECTION: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
The aim of the work is to evaluate the efficacy of the sub lingual prostaglandin E1 synthetic analogue (misoprostol) before IUD insertion to facilitate the procedure in patients delivered before only by cesarean section.
详细描述
The study will be conducted at Ain Shams University Maternity Hospital. 124 women candidate for Cu T 380A IUD insertion will be enrolled in the study. Half of them will receive 400 micro gram of misoprostol (Sigma) sub lingually and the other half will receive the placebo two hours before IUD insertion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Normal size uterus.
- •Willing to participate.
- •Candidate for IUD insertion.
- •Delivered only by cesarean section.
- •Last delivery is more than 40 days before participating in the study.
排除标准
- •Previous vaginal delivery
- •Signs of genital infection.
- •Menopause.
- •Body mass index (BMI) > 35 kg/m
- •Contraindication to misoprostol.
- •Copper allergy.
- •Positive pregnancy test.
- •Had a prior attempt for IUD insertion.
- •Uterine anomalies.
- •Uterine fibroid.
研究组 & 干预措施
Misoprostol
Women will receive two sub lingual tablets each containing 200 micro gram misoprostol (Misotac), receiving a total dose of 400 micro grams. Two hour later, Cu T 380A IUD (PREGNA) will be inserted.
干预措施: Misoprostol (Drug)
Placebo
Women will receive two sub lingual placebo tablets which will be similar in size, color, odor and shape to the misoprostol tablets. Two hour later, Cu T 380A IUD (PREGNA) will be inserted.
干预措施: Placebo (Drug)
结局指标
主要结局
Pain
时间窗: During the procedure
The perception of pain and discomfort as described by the patient assessed by Visual Analogue Scale (VAS). The scale will be graded from 0 to 10, 0 representing no pain at all and 10 worst possible imaginable pain.
次要结局
- Complications(During the procedure and the following 24 hours.)
- Difficulty of Procedure(During the procedure)
研究者
Mohamed S Sweed, MD
Mohamed S. Sweed lecturer of Obstetrics & Gynecology AinShams University.
Ain Shams University