Comparison Between 2 Doses of Misoprostol Before Intrauterine Device

March 12, 2017 updated by: Ahmed Mohamed Abbas, Assiut University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

212

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo
      • Assiut, Cairo, Egypt, 002
        • Ahmed Abbas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: misoprostol 200
misoprostol 200 microgram placed into the vagina 3 hours prior to having the intrauterine device inserted
Drug: misoprostol 200
Active Comparator: misoprostol 400
misoprostol 400 microgram placed into the vagina 3 hours prior to having the intrauterine device inserted
Drug: misoprostol 400

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean pain score during intrauterine device insertion
Time Frame: 5 minutes
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

September 10, 2016

First Submitted That Met QC Criteria

September 10, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Actual)

March 14, 2017

Last Update Submitted That Met QC Criteria

March 12, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MISO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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