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

Phase 4

Completed

• Conditions: Intrauterine Device
• Interventions: Drug: Placebo; Drug: Dinoprostone

• Registration Number: NCT04045548
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2019-08-02
• Study First Submitted QC: 2019-08-02
• Study First Posted: 2019-08-05
• Study Start: 2019-08-10
• Status Verified: 2020-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-05
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	one tablet of placebo inserted by the study nurse 2 hours before IUD insertion.
dinoprostone	Dinoprostone	1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 2 hours before IUD insertion.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

faculty of medicine Cairo university; 🇪🇬 Cairo, Egypt