Vaginal Dinoprostone Administration Prior to an Intrauterine Device Insertion in Multiparous Women.

Phase 4

Completed

• Conditions: IUD Insertion
• Interventions: Drug: placebo; Drug: Dinoprostone

• Registration Number: NCT04046302
• Lead Sponsor: Cairo University

Brief Summary

To investigate whether vaginal dinoprostone administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications, and pain in multiparous women.

Detailed Description

Women may experience pain and technical difficulties may be encountered when insertion of an intrauterine device (IUD) is attempted through a narrow cervical canal.IUD insertion- related complications and side effects are more common among women who had never delivered vaginally. Pain can be perceived during all steps of IUD insertion including the application of the tenaculum to the cervical lip, sounding the uterus and advancing the IUD introducer through the cervical canal inside the uterine cavity

Study Timeline

• Study First Submitted: 2019-08-04
• Study First Submitted QC: 2019-08-04
• Study First Posted: 2019-08-06
• Study Start: 2019-08-30
• Primary Completion: 2020-01-10
• Study Completion: 2020-01-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-07
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

• multiparous women aged over 18 years of age requesting an IUD for contraception, had a negative pregnancy test.

Exclusion Criteria

• currently pregnant or were pregnant within 6 weeks of study entry
• had a prior attempted or successful IUD insertion
• had a history of a cervical procedure such as cone biopsy, Loop electrosurgical excision procedure, or cryotherapy
• any World Health Organization Medical Eligibility Criteria category 3 or 4 precaution to an IUD
• active vaginitis or cervicitis
• undiagnosed abnormal uterine bleeding
• pelvic inflammatory disease within the last 3 months
• fibroids or other uterine abnormalities distorting the uterine cavity
• contraindication or allergy to dinoprostone.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	one tablet of placebo self-inserted by the patients 3 hours before the scheduled IUD insertion appointment.
dinoprostone	Dinoprostone	1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) self-inserted by the patients 3 hours before the scheduled IUD insertion appointment.

Primary Outcome Measures

Name	Time	Method
the difference in the pain intensity scores between the study groups	5 minutes	the difference in the pain intensity scores between the study groups by visual analog scale score which ranges from zero to 10.where zero represents no pain and 10 represents the most worst pain

Trial Locations

Locations (1)

faculty of medicine Cairo university; 🇪🇬 Giza, Egypt