Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Women

Not Applicable

• Conditions: IUCD Complication
• Interventions: Drug: dinoprostol; Drug: placebo; Drug: misoprostol

• Registration Number: NCT04505917
• Lead Sponsor: Aswan University Hospital

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 multiparous overweight and obese women

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: 2020-08
• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-08-07
• Study First Posted: 2020-08-10
• Last Update Submitted: 2020-08-15
• Last Update Posted: 2020-08-18
• Study Start: 2020-09-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-08-30

Recruitment & Eligibility

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

Inclusion Criteria

• multi parous women requesting copper IUD insertion
• body mass index more than 25

Exclusion Criteria

• pregnancy,
• null parous women,
• contraindications or allergy to dinoprostone or misoprostol,contraindication to IUD insertion,
• untreated active cervicitis or vaginitis,
• undiagnosed abnormal uterine bleeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dinoprostone	dinoprostol	2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion.
placebo	placebo	Placebo Comparator: placebo 2 tablet of placebo inserted by the study nurse 3 hours before IUD insertion.
misoprostol	misoprostol	2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Intensity of pain: visual analogue scale	30 minutes after the procedure	Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10
the ease of IUD insertion	10 minutes	the ease of IUD insertion using ease of insertion score from 0 to 10 cm (0 = very easy insertion, 10 cm = terribly difficult insertion)
women's satisfaction level: score	10 minutes	women's satisfaction level using satisfaction score from 0 to 10 cm where 0 denotes no satisfaction and 10 denotes maximum satisfaction
the difference in visual analog scale pain scores during tenaculum application	10 minutes	The difference in pain scores during tenaculum application using a visual analog scale from 0 to 10

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt