Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Women Delivered Only by Cesarean Delivery

NCT ID: NCT04080349

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-10
• Study Completion Date: 2019-12-05

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 women delivered only by cesarean section.

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.

Conditions

IUD Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

dinoprostone

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

Group Type: EXPERIMENTAL

Dinoprostone 3 mg

Intervention Type: DRUG

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

misoprostol

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

Group Type: ACTIVE_COMPARATOR

Misoprostol 200Mcg Tab

Intervention Type: DRUG

1 vaginal tablet of misoprostol (200 mcg) (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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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

Interventions

Dinoprostone 3 mg

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

Intervention Type: DRUG

Misoprostol 200Mcg Tab

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

Intervention Type: DRUG

placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• women delivered only by elective cesarean section and not received analgesics in the last 24 hours

Exclusion Criteria

• contraindications to dinoprostone or misoprostol or IUD insertion and allergy to study drugs.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Samy aly ashour

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AHMED SAMY

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Central Contacts

AHMED SAMY, MD

Role: CONTACT

ahmedsamy8233@gmail.com

+201100681167

Other Identifiers

dinoprostone misoprostol IUDs

Identifier Type: -

Identifier Source: org_study_id