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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04045548

Collaborator

(none)

200

Enrollment

Location

Arms

4.9

Actual Duration (Months)

41.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intrauterine Device	Drug: Dinoprostone 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 :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

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

Primary Purpose:

Treatment

Official Title:

Benefits of Vaginal Dinoprostone Administration Prior to Levonorgestrel-releasing Intrauterine System Insertion in Women Delivered Only by Elective Cesarean Section: a Randomized Double-blind Clinical Trial.

Actual Study Start Date :

Aug 10, 2019

Actual Primary Completion Date :

Jan 1, 2020

Actual Study Completion Date :

Jan 5, 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 2 hours before IUD insertion.	Drug: Dinoprostone 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 6 hours before IUD insertion.
Placebo Comparator: placebo one tablet of placebo inserted by the study nurse 2 hours before IUD insertion.	Drug: Placebo one tablet of placebo inserted by the study nurse 6 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 2 hours before IUD insertion.

Drug: Dinoprostone

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

Placebo Comparator: placebo

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

Drug: Placebo

one tablet of placebo inserted by the study nurse 6 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	faculty of medicine Cairo university	Cairo		Egypt	11231

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: AHMED SAMY, 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:

NCT04045548

Other Study ID Numbers:

dinoprostone IUD

First Posted:

Aug 5, 2019

Last Update Posted:

Jan 13, 2020

Last Verified:

Jan 1, 2020

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

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

Additional relevant MeSH terms:

Dinoprostone

Study Results

No Results Posted as of Jan 13, 2020