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

IUD Insertion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02141321
• Other study ID #: 9010023
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 15, 2014
• Last updated: March 17, 2015
• Start date: May 2014
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• IUD Insertion

Intervention

Drug:
• Misoprostol

• Placebo

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	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	No
Secondary	Difficulty of 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	No
Secondary	Complications	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.	No