Comparison Between 2 Doses of Misoprostol Before Intrauterine Device

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT02901561

Collaborator

(none)

212

Enrollment

Location

Arms

Duration (Months)

52.9

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Sep 1, 2016

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Mean pain score during intrauterine device insertion [5 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Abbas	Assiut	Cairo	Egypt	002

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Mohamed Abbas, Dr, Assiut University

ClinicalTrials.gov Identifier:

NCT02901561

Other Study ID Numbers:

MISO

First Posted:

Sep 15, 2016

Last Update Posted:

Mar 14, 2017

Last Verified:

Mar 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Misoprostol

Study Results

No Results Posted as of Mar 14, 2017