Vaginal Misoprostol and Dinoprostone and Isonicotinic Acid Hydrazide Prior to Copper Intrauterine Device Insertion

Not Applicable

• Conditions: IUCD Complication
• Interventions: Drug: dinoprostine; Drug: Isonicotinic Acid Hydrazide; Drug: misoprostol

• Registration Number: NCT04505943
• Lead Sponsor: Aswan University Hospital

Brief Summary

To compare the effect of vaginal dinoprostone versus vaginal misoprostol and Isonicotinic Acid Hydrazide administered before the copper intrauterine device(IUD) insertion in reducing IUD inertion pain and the difficulty in inserting the IUD in nulliparous 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: 2021-07-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

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

Inclusion Criteria

• nulliparous women requesting copper IUD insertion

Exclusion Criteria

• pregnancy,
• 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	dinoprostine	2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 12 hours before IUD insertion.
isonicotinic acid hydrazide	Isonicotinic Acid Hydrazide	2vaginal tablet of isonicotinic acid hydrazide inserted by the study nurse12 hours before IUD insertion.
misoprostol	misoprostol	2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 12hours 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
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)
the difference in visual analog scale pain scores during tenaculum application	10 minuts	The difference in pain scores during tenaculum application using a visual analog scale from 0 to 10
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

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt