Vaginal Misoprostol Before Intrauterine Contraceptive Device Insertion

Phase 3

Completed

• Conditions: Contraception
• Interventions: Drug: Placebos; Drug: Misoprostol

• Registration Number: NCT03790371
• Lead Sponsor: Ain Shams University

Brief Summary

the current study was conducted to assess efficacy of vaginal misoprostol before IUD insertion following previous insertion failure

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-01
• Primary Completion: 2016-08-01
• Study Completion: 2016-08-01
• Status Verified: 2018-12
• Study First Submitted: 2018-12-27
• Study First Submitted QC: 2018-12-27
• Last Update Submitted: 2018-12-27
• Study First Posted: 2018-12-31
• Last Update Posted: 2018-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

One previous failed attempt of IUD insertion.

Exclusion Criteria

1. Uterine fibroid distorting the cavity.
2. Anatomical uterine abnormality with distortion of the cavity
3. Current pelvic inflammatory disease or recently treated pelvic inflammatory disease (PID) in the last three months.
4. Current purulent cervicitis (chlamydia or gonorrhea).
5. Immediately after septic abortion.
6. Uterus size less than 6 cm and more than 9 cm.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebos	while the control group received a placebo tablet in the same regimen as the study group.
misoprostol group	Misoprostol	misoprostol (misotac® sigma pharmaceutical industries) 200 mcg vaginally applied ten and four hours prior to the second attempt of IUD insertion

Primary Outcome Measures

Name	Time	Method
the success rate for IUD insertion.	four hours after misoprostol dose	the success of IUD insertion after previous attempt failure

Trial Locations

Locations (1)

AinShams university maternity hospital; 🇪🇬 Cairo, Abbassya, Egypt