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

Phase 2

Completed

• Conditions: IUD Insertion
• Interventions: Drug: Placebo; Drug: Misoprostol

• Registration Number: NCT02141321
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-15
• Study First Submitted QC: 2014-05-16
• Study First Posted: 2014-05-19
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 124

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Misoprostol	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.

Primary Outcome Measures

Name	Time	Method
Pain	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.

Secondary Outcome Measures

Name	Time	Method
Complications	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.
Difficulty of Procedure	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).

Trial Locations

Locations (1)

Ain Shams University Maternity Hospital; 🇪🇬 Cairo, Egypt