- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04500028
Vaginal Isonicotinic Acid Hydrazide Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System
May 12, 2022 updated by: hany farouk, Aswan University Hospital
Clinical Outcomes of Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to Levonorgestrel Releasing Intrauterine System Insertion in Women Delivered Only by Elective Cesarean Section: a Randomized Double Blinded Clinical Trial
To investigate whether vaginal isonicotinic acid hydrazide (INH) administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces failed insertions, insertion-related complications, and pain in Women With no Previous Vaginal Delivery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide.
The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women.
However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use.
Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.
Study Type
Interventional
Enrollment (Actual)
220
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
-
-
-
Aswan, Egypt, 81528
- Aswan University Hospital
-
-
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 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Non-pregnant women
- Women that did not receive any analgesics or Dinoprostone in the 24 hours prior to insertion
- Women who delivered only by cesarean section
Exclusion Criteria:
- Women with any uterine abnormalities such as congenital anomalies, endometrial lesions, adenomyosis, or fibroids.
- Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use
- Allergy to isonicotinic acid hydrazide
- known psychiatric disorders ( anxiety and depression) and chronic use of medications that could interfere with pain perception (antidepressants and anticonvulsants)
- Women refuse to participate in the study
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: INH
3 vaginal tablet of isonicotinic acid hydrazide (900mg) ( inserted by the study nurse 4 hours before IUD insertion.
|
3 vaginal tablet of isonicotinic acid hydrazide (900mg) inserted by the study nurse 4 hours before IUD insertion.
|
Placebo Comparator: Placebo Comparator
one tablet of placebo inserted by the study nurse 4 hours before IUD insertion.
|
3 tablet of placebo inserted by the study nurse 4 hours before IUD insertion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The difference in pain scores during intrauterine device insertion
Time Frame: 10 minutes
|
The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
duration of IUD insertion
Time Frame: 10 minutes
|
duration of IUD insertion measured in minutes
|
10 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 (Actual)
August 1, 2020
Primary Completion (Actual)
October 31, 2021
Study Completion (Actual)
December 1, 2021
Study Registration Dates
First Submitted
August 2, 2020
First Submitted That Met QC Criteria
August 2, 2020
First Posted (Actual)
August 5, 2020
Study Record Updates
Last Update Posted (Actual)
May 13, 2022
Last Update Submitted That Met QC Criteria
May 12, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- aswu/355/3/19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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