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

Intrauterine Device Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04045548
• Other study ID #: dinoprostone IUD
• Status: Completed
• Phase: Phase 4
• Start date: August 10, 2019
• Est. completion date: January 5, 2020

Study information

• Verified date: January 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 5, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Intrauterine Device

Intervention

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

Locations

Country	Name	City	State
Egypt	faculty of medicine Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in pain scores during intrauterine device insertion	The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10	10 minutes