Comparison Between 2 Doses of Misoprostol Before Intrauterine Device

Phase 2

Completed

• Conditions: Pain Relief
• Interventions: Drug: misoprostol 400; Drug: misoprostol 200

• Registration Number: NCT02901561
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-10
• Study First Submitted QC: 2016-09-10
• Study First Posted: 2016-09-15
• Primary Completion: 2016-12
• Study Completion: 2017-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-12
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 212

Inclusion Criteria

• • Women not taken analgesics or anxiolytics in the 24 hours prior insertion

  • Women who will accept to participate in the study

Exclusion Criteria

• Any contraindication to IUD placement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
misoprostol 400	misoprostol 400	misoprostol 400 microgram placed into the vagina 3 hours prior to having the intrauterine device inserted
misoprostol 200	misoprostol 200	misoprostol 200 microgram placed into the vagina 3 hours prior to having the intrauterine device inserted

Primary Outcome Measures

Name	Time	Method
Mean pain score during intrauterine device insertion	5 minutes

Trial Locations

Locations (1)

Ahmed Abbas; 🇪🇬 Assiut, Cairo, Egypt