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

March 7, 2020 updated by: Ahmed Samy aly ashour, Cairo University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 11231
        • Faculty of Medicine Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the difference in the pain intensity scores between the study groups
Time Frame: 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
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 30, 2019

Primary Completion (ACTUAL)

January 10, 2020

Study Completion (ACTUAL)

January 30, 2020

Study Registration Dates

First Submitted

August 4, 2019

First Submitted That Met QC Criteria

August 4, 2019

First Posted (ACTUAL)

August 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 7, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • dinoprostone IUD pain

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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