Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison Between 2 Doses of Misoprostol Before Intrauterine Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02901561
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

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

Condition or disease Intervention/treatment Phase
Pain Relief Drug: misoprostol 200 Drug: misoprostol 400 Phase 2 Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison Between 2 Different Doses of Vaginal Misoprostol Before Intrauterine Device Insertion in Parous Women
Study Start Date : September 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

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



Primary Outcome Measures :
  1. Mean pain score during intrauterine device insertion [ Time Frame: 5 minutes ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901561


Locations
Layout table for location information
Egypt
Ahmed Abbas
Assiut, Cairo, Egypt, 002
Sponsors and Collaborators
Assiut University

Layout table for additonal information
Responsible Party: Ahmed Mohamed Abbas, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT02901561     History of Changes
Other Study ID Numbers: MISO
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics