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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04080336

Collaborator

(none)

129

Enrollment

Location

Arms

4.3

Actual Duration (Months)

29.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
IUD Insertion Complication	Drug: Dinoprostone Drug: Misoprostol Drug: placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

129 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 10, 2019

Actual Primary Completion Date :

Dec 20, 2019

Actual Study Completion Date :

Jan 20, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: dinoprostone

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion.

Drug: Dinoprostone

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 3hours before IUD insertion.

Active Comparator: misoprostol

1 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.

Drug: Misoprostol

1 vaginal tablet of misoprostol (200mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.

Placebo Comparator: placebo

one tablet of placebo inserted by the study nurse 3 hours before IUD insertion.

Drug: placebo

one tablet of placebo inserted by the study nurse 3 hours before IUD insertion.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

the difference in pain scores during tenaculum application [10 minutes]
The difference in pain scores during tenaculum application using a visual analog scale from 0 to 10
the difference in pain scores during sound insertion [10 minutes]
The difference in pain scores during sound insertion using a visual analog scale 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 [10 minutes]
women's satisfaction level using satisfaction score from 0 to 10 cm where 0 denotes no satisfaction and 10 denotes maximum satisfaction

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Samy	Giza		Egypt	11231

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: AHMED SAMY, Cairo University
Principal Investigator: Mohamed El Sharkawy, Cairo University
Principal Investigator: Mohamed El Mahy, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Samy aly ashour, assistant professor, Cairo University

ClinicalTrials.gov Identifier:

NCT04080336

Other Study ID Numbers:

dinoprostone misoprostol IUD

First Posted:

Sep 6, 2019

Last Update Posted:

Jun 30, 2020

Last Verified:

Jun 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Misoprostol

Dinoprostone

Study Results

No Results Posted as of Jun 30, 2020