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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04046302

Collaborator

(none)

160

Enrollment

Location

Arms

Actual Duration (Months)

31.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
IUD Insertion	Drug: Dinoprostone Drug: placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 30, 2019

Actual Primary Completion Date :

Jan 10, 2020

Actual Study Completion Date :

Jan 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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 Comparator: placebo one tablet of placebo self-inserted by the patients 3 hours before the scheduled IUD insertion appointment.	Drug: placebo one tablet of placebo self-inserted by participants 3 hours before scheduled IUD insertion appointment.

Arm

Intervention/Treatment

Experimental: 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.

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 Comparator: placebo

one tablet of placebo self-inserted by the patients 3 hours before the scheduled IUD insertion appointment.

Drug: placebo

one tablet of placebo self-inserted by participants 3 hours before scheduled IUD insertion appointment.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

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:

NCT04046302

Other Study ID Numbers:

dinoprostone IUD pain

First Posted:

Aug 6, 2019

Last Update Posted:

Mar 10, 2020

Last Verified:

Mar 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dinoprostone

Study Results

No Results Posted as of Mar 10, 2020