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

IUD Insertion Clinical Trial

Official title:

Effect of Self-Administered Vaginal Dinoprostone on Pain Perception During Copper Intrauterine Device Insertion in Parous Women: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04046302
• Other study ID #: dinoprostone IUD pain
• Status: Completed
• Phase: Phase 4
• Start date: August 30, 2019
• Est. completion date: January 30, 2020

Study information

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

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 30, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 in?ammatory disease within the last 3 months

• ?broids or other uterine abnormalities distorting the uterine cavity

• contraindication or allergy to dinoprostone.

Related Conditions & MeSH terms

• IUD Insertion

Intervention

Drug:
• Dinoprostone
1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) self-inserted by participants 3 hours before scheduled IUD insertion appointment.
• placebo
one tablet of placebo self-inserted by participants 3 hours before scheduled IUD insertion appointment.

Locations

Country	Name	City	State
Egypt	faculty of medicine Cairo university	Giza

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 the pain intensity scores between the study groups	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	5 minutes