Dinoprostone vs Misoprostol Before LNG-IUD Insertion

March 9, 2020 updated by: Ahmed Samy aly ashour, Cairo University

Comparative Study Between Vaginal Dinoprostone and Vaginal Misoprostol Prior to IUD Insertion in Multiparous Women

the aim of this study is to compare the safety and efficacy of vaginal dinoprostone vs vaginal misoprostol administration prior to IUD insertion in multiparous women regarding reduction in iud insertion pain

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • multiparous women requesting IUD insetion

Exclusion Criteria:

  • active genital infection,uterine anomalies, and contraindication or allergy to dinoprostone or misoprostol

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vaginal dinoprostone
vaginal dinoprostone 6 mg (two tablets) 3 hours prior to IUD insertion
Drug: vaginal dinoprostone
two tablets of vaginal dinoprostone (6 mg) 3 hours prior to IUD insertion
Active Comparator: vaginal misoprostol
vaginal misoprostol 400 mcg (two tablets) 3 hours prior to IUD insertion
Drug: vaginal misoprostol
two tablets of vaginal misoprostol (400 mcg) 3 hours prior to IUD insertion
Placebo Comparator: placebo
two tablets of placebo similar in shape ,color, odor to the study drugs
Drug: placebo
two tablets of placebo given 3 hours prior to IUD insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain during IUD insertion: visual analog scale
Time Frame: 2 minutes
pain during IUD insertion assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable
2 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of IUD insertion
Time Frame: 5 minutes
duration of IUD insertion measured in minutes
5 minutes

Collaborators and Investigators

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

Sponsor

Cairo University

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 (Anticipated)

March 15, 2020

Primary Completion (Anticipated)

June 15, 2020

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

March 6, 2020

First Submitted That Met QC Criteria

March 9, 2020

First Posted (Actual)

March 10, 2020

Study Record Updates

Last Update Posted (Actual)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • dinoprostone IUDs

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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