Vaginal Dinoprostone Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System in Women With no Previous Vaginal Delivery

NCT ID: NCT04045548

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-10
• Study Completion Date: 2020-01-05

Brief Summary

To investigate whether vaginal dinoprostone administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces failed insertions, insertion-related complications, and pain in Women With no Previous Vaginal Delivery.

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

Intrauterine Device

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 2 hours before IUD insertion.

Group Type: EXPERIMENTAL

Dinoprostone

Intervention Type: DRUG

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 6 hours before IUD insertion.

placebo

one tablet of placebo inserted by the study nurse 2 hours before IUD insertion.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

one tablet of placebo inserted by the study nurse 6 hours before IUD insertion.

Interventions

Dinoprostone

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 6 hours before IUD insertion.

Intervention Type: DRUG

Placebo

one tablet of placebo inserted by the study nurse 6 hours before IUD insertion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Non-pregnant women
• Women that did not receive any analgesics or Dinoprostone in the 24 hours prior to insertion
• Women who delivered only by cesarean section

Exclusion Criteria

• Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids.
• Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use
• Allergy to dinoprostone.
• Women refuse to participate in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 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

Locations

faculty of medicine Cairo university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

dinoprostone IUD

Identifier Type: -

Identifier Source: org_study_id