Sub Lingual Misoprostol Before IUD Insertion in Women With Only Previous Cesarean Section

March 17, 2015 updated by: Mohamed S Sweed, MD, Ain Shams University

SUB LINGUAL MISOPROSTOL PRIOR TO IUD INSERTION IN WOMEN WITH ONLY PREVIOUS CESARIAN SECTION: A Randomized Controlled Trial

The aim of the work is to evaluate the efficacy of the sub lingual prostaglandin E1 synthetic analogue (misoprostol) before IUD insertion to facilitate the procedure in patients delivered before only by cesarean section.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted at Ain Shams University Maternity Hospital. 124 women candidate for Cu T 380A IUD insertion will be enrolled in the study. Half of them will receive 400 micro gram of misoprostol (Sigma) sub lingually and the other half will receive the placebo two hours before IUD insertion.

Study Type

Interventional

Enrollment (Actual)

124

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, Egypt
        • Ain shams university maternity hospital

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

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Normal size uterus.
  • Willing to participate.
  • Candidate for IUD insertion.
  • Delivered only by cesarean section.
  • Last delivery is more than 40 days before participating in the study.

Exclusion Criteria:

  • Previous vaginal delivery
  • Signs of genital infection.
  • Menopause.
  • Body mass index (BMI) > 35 kg/m2.
  • Contraindication to misoprostol.
  • Copper allergy.
  • Positive pregnancy test.
  • Had a prior attempt for IUD insertion.
  • Uterine anomalies.
  • Uterine fibroid.

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

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Misoprostol
Women will receive two sub lingual tablets each containing 200 micro gram misoprostol (Misotac), receiving a total dose of 400 micro grams. Two hour later, Cu T 380A IUD (PREGNA) will be inserted.
Drug: Misoprostol
Other Names:
  • Cytotec
  • Misotac
  • Misotec
  • Prostaglandin E1 synthetic analogue
PLACEBO_COMPARATOR: Placebo
Women will receive two sub lingual placebo tablets which will be similar in size, color, odor and shape to the misoprostol tablets. Two hour later, Cu T 380A IUD (PREGNA) will be inserted.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: During the procedure
The perception of pain and discomfort as described by the patient assessed by Visual Analogue Scale (VAS). The scale will be graded from 0 to 10, 0 representing no pain at all and 10 worst possible imaginable pain.
During the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difficulty of Procedure
Time Frame: During the procedure
The degree of difficulty of the IUD insertion judged by the investigator as the resistance met at the internal cervical os. The procedure either graded as (easy), (moderate difficulty) or (difficult) or (failed insertion).
During the procedure
Complications
Time Frame: During the procedure and the following 24 hours.
Uterine perforation, excessive bleeding, fever, IUD expulsion or any other unexpected complications will be assessed during the procedure and followed for the next 24 hours.
During the procedure and the following 24 hours.

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Study Director: Hassan A. Bayoumy, Professor, ain shams University
  • Principal Investigator: Mohamed Y. Mohamed, M.B., B.Ch., 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

May 1, 2014

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

May 15, 2014

First Submitted That Met QC Criteria

May 16, 2014

First Posted (ESTIMATE)

May 19, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9010023

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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