Vaginal Dinoprostone Administration Prior to Intrauterine Device Insertion

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04079140
• Collaborator: (none)
• Enrollment: 130
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.8
• Patients Per Site Per Month: 46

Study Details

Study Description

Brief Summary

To investigate whether vaginal dinoprostone administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces IUD insertion pain and difficulty in insertion in adolescents and young women.

Condition or Disease	Intervention/Treatment	Phase
IUD Insertion Pain	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: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Benefits of Self-administered Vaginal Dinoprostone Administration 12 Hours Prior to Intrauterine Device Insertion in Adolescent and Young Women: a Randomized Controlled Trial
• Actual Study Start Date: Sep 15, 2019
• Actual Primary Completion Date: Nov 30, 2019
• Actual Study Completion Date: Dec 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dinoprostone 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) self-inserted by the patient 12 hours before IUD insertion.	Drug: Dinoprostone; 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) self-inserted by the patient 12 hours before IUD insertion.
Placebo Comparator: placebo one tablet of placebo self-administered by the patient 12 hours before IUD insertion.	Drug: placebo; one tablet of placebo self-inserted by the patient 12 hours before IUD insertion.

Outcome Measures

Primary Outcome Measures

1. 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 22 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• nulliparous adolescent and young women requesting levonorgestrel-releasing intrauterine device

Exclusion Criteria:

• pregnancy and contraindication or allergy to dinoprostone or contraindication to IUD insertion, chronic pelvic pain,pelvic inflammatory disease,analgesic intake 24 hours prior to IUD insertion.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	faculty of medicine Cairo university	Giza		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: NCT04079140
• Other Study ID Numbers: vaginal dinoprostone IUD
• First Posted: Sep 6, 2019
• Last Update Posted: Jul 31, 2020
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dinoprostone

Study Results

No Results Posted as of Jul 31, 2020