Dinoprostone vs Misoprostol Before LNG-IUD Insertion

Phase 3

• Conditions: IUD Insertion Pain
• Interventions: Drug: placebo; Drug: vaginal dinoprostone; Drug: vaginal misoprostol

• Registration Number: NCT04301349
• Lead Sponsor: Cairo University

Brief Summary

the aim of this study is to compare the safety and efficacy of vaginal dinoprostone vs vaginal misoprostol administration prior to IUD insertion in multiparous women regarding reduction in iud insertion pain

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-09
• Last Update Submitted: 2020-03-09
• Study First Posted: 2020-03-10
• Last Update Posted: 2020-03-10
• Study Start: 2020-03-15
• Primary Completion: 2020-06-15
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• multiparous women requesting IUD insetion

Exclusion Criteria

• active genital infection,uterine anomalies, and contraindication or allergy to dinoprostone or misoprostol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	two tablets of placebo similar in shape ,color, odor to the study drugs
vaginal dinoprostone	vaginal dinoprostone	vaginal dinoprostone 6 mg (two tablets) 3 hours prior to IUD insertion
vaginal misoprostol	vaginal misoprostol	vaginal misoprostol 400 mcg (two tablets) 3 hours prior to IUD insertion

Primary Outcome Measures

Name	Time	Method
pain during IUD insertion: visual analog scale	2 minutes	pain during IUD insertion assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable

Secondary Outcome Measures

Name	Time	Method
duration of IUD insertion	5 minutes	duration of IUD insertion measured in minutes