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临床试验/NCT02901561
NCT02901561已完成2 期

Comparison Between 2 Different Doses of Vaginal Misoprostol Before Intrauterine Device Insertion in Parous Women

Assiut University1 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2016年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
212
试验地点
1
主要终点
Mean pain score during intrauterine device insertion

研究概览

简要总结

The purpose of the investigators' study was to evaluate whether misoprostol will improve pain scores .

详细描述

an intrauterine device can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the intrauterine device insertion tube, and removing the tube; and placement of the device in the uterus.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
20 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • • Women not taken analgesics or anxiolytics in the 24 hours prior insertion
  • Women who will accept to participate in the study

排除标准

  • Any contraindication to IUD placement

研究组 & 干预措施

misoprostol 200

Experimental

misoprostol 200 microgram placed into the vagina 3 hours prior to having the intrauterine device inserted

干预措施: misoprostol 200 (Drug)

misoprostol 400

Active Comparator

misoprostol 400 microgram placed into the vagina 3 hours prior to having the intrauterine device inserted

干预措施: misoprostol 400 (Drug)

结局指标

主要结局

Mean pain score during intrauterine device insertion

时间窗: 5 minutes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohamed Abbas

Dr

Assiut University

研究点 (1)

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