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

IUD Insertion Complication Clinical Trial

Official title:

Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Nulliparous Women:a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04080336
• Other study ID #: dinoprostone misoprostol IUD
• Status: Completed
• Phase: Phase 4
• Start date: September 10, 2019
• Est. completion date: January 20, 2020

Study information

• Verified date: June 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the effect of vaginal dinoprostone versus vaginal misoprostol administered before the copper intrauterine device(IUD) insertion in reducing IUD inertion pain and the difficulty in inserting the IUD in nulliparous women.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: January 20, 2020
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• IUD Insertion Complication

Intervention

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

Locations

Country	Name	City	State
Egypt	Ahmed Samy	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in pain scores during intrauterine device insertion	The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10	10 minutes
Secondary	the difference in pain scores during tenaculum application	The difference in pain scores during tenaculum application using a visual analog scale from 0 to 10	10 minutes
Secondary	the difference in pain scores during sound insertion	The difference in pain scores during sound insertion using a visual analog scale from 0 to 10	10 minutes
Secondary	the ease of IUD insertion	the ease of IUD insertion using ease of insertion score from 0 to 10 cm (0 = very easy insertion, 10 cm = terribly difficult insertion)	10 minutes
Secondary	women's satisfaction level	women's satisfaction level using satisfaction score from 0 to 10 cm where 0 denotes no satisfaction and 10 denotes maximum satisfaction	10 minutes