Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Women Delivered Only by Cesarean Delivery

Phase 4

• Conditions: IUD Pain
• Interventions: Drug: Misoprostol 200Mcg Tab; Drug: Dinoprostone 3 mg; Drug: placebo

• Registration Number: NCT04080349
• Lead Sponsor: Cairo University

Brief Summary

To compare the effect of vaginal dinoprostone versus vaginal misoprostol administered before the copper intrauterine device(IUD) insertion in reducing IUD insertion pain and the difficulty in inserting the IUD in women delivered only by cesarean section.

Detailed Description

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-04
• Last Update Submitted: 2019-09-04
• Study First Posted: 2019-09-06
• Last Update Posted: 2019-09-06
• Study Start: 2019-09-10
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• women delivered only by elective cesarean section and not received analgesics in the last 24 hours

Exclusion Criteria

• contraindications to dinoprostone or misoprostol or IUD insertion and allergy to study drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
misoprostol	Misoprostol 200Mcg Tab	1 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.
dinoprostone	Dinoprostone 3 mg	1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion.
placebo	placebo	one tablet of placebo inserted by the study nurse 3 hours before IUD insertion.

Primary Outcome Measures

Name	Time	Method
The difference in pain scores during intrauterine device insertion	10 minutes	The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10