- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04301349
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.
Study Contact
- Name: AHMED SAMY, MD
- Phone Number: +201100681167
- Email: ahmedsamy8233@gmail.com
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
|
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
|
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
|
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
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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