Comparison Between 2 Doses of Misoprostol Before Intrauterine Device

Pain Relief Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02901561
• Other study ID #: MISO
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 10, 2016
• Last updated: March 12, 2017
• Start date: September 2016
• Est. completion date: January 2017

Study information

• Verified date: March 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain Relief

Intervention

Drug:
• misoprostol 200

• misoprostol 400

Locations

Country	Name	City	State
Egypt	Ahmed Abbas	Assiut	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean pain score during intrauterine device insertion		5 minutes