Comparison Between 2 Doses of Misoprostol Before Intrauterine Device

NCT ID: NCT02901561

Last Updated: 2017-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pain Relief

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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misoprostol 200

misoprostol 200 microgram placed into the vagina 3 hours prior to having the intrauterine device inserted

Group Type EXPERIMENTAL

misoprostol 200

Intervention Type DRUG

misoprostol 400

misoprostol 400 microgram placed into the vagina 3 hours prior to having the intrauterine device inserted

Group Type ACTIVE_COMPARATOR

misoprostol 400

Intervention Type DRUG

Interventions

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misoprostol 200

Intervention Type DRUG

misoprostol 400

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ahmed Abbas

Assiut, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MISO

Identifier Type: -

Identifier Source: org_study_id

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