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

NCT ID: NCT02141321

Last Updated: 2015-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-01-31

Brief Summary

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.

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.

Conditions

IUD Insertion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Misoprostol

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Misoprostol

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Misotac; Cytotec; Misotec; Prostaglandin E1 synthetic analogue

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed S Sweed, MD

Mohamed S. Sweed lecturer of Obstetrics & Gynecology AinShams University.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed S. Sweed, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Hassan A. Bayoumy, Professor

Role: STUDY_DIRECTOR

Ain Shams University

Mohamed Y. Mohamed, M.B., B.Ch.

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Ain Shams University Maternity Hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

9010023

Identifier Type: -

Identifier Source: org_study_id