Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to T380A Intrauterine Device Insertion

August 6, 2021 updated by: hany farouk, Aswan University Hospital

Clinical Outcomes of Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to T380A Intrauterine Device Insertion in Women Delivered Only by Cesarean Delivery: a Randomized Double Blinded Clinical Trial

To investigate whether vaginal isonicotinic acid hydrazide administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications and pain in in Women Delivered Only by Cesarean Delivery.

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 is attempted through a narrow cervical canal. intrauterine device insertion- related complications and side effects are more common among women who had never delivered vaginally.

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

  • Egypt
      • 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 as congenital anomalies, endometrial lesions, adenomyosis, 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 .
  • 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 self-inserted by the patient 12 hours before IUD insertion.
Drug: INH
3 vaginal tablet of isonicotinic acid hydrazide self inserted 12 hours before IUD insertion.
Other Names:
  • isonicotinic acid hydrazide
Placebo Comparator: Placebo Comparator
3 vaginal tablet of Placebo Comparator self-inserted by the patient 12 hours before IUD insertion.
Drug: Placebo Comparator
3 vaginal tablet of Placebo Comparator self inserted 12 hours before IUD insertion

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: 10 minutes
the difference in the pain intensity scores between the study groups at IUD insertion BY10 cm visual analog scale score where 0 denotes no pain and 10 denotes the most imaginable pain
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
insertion time
Time Frame: 10 minutes
IUD insertion time from speculum in to speculum out
10 minutes
Provider ease of insertion
Time Frame: 10 minutes
Provider ease of insertion was evaluated using a visual analog scale from 0 to 10 cm where 0 denotes very easy insertion and 10 denotes a very difficult insertion.
10 minutes

Collaborators and Investigators

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

Sponsor

Aswan University Hospital

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)

September 1, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

August 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)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 6, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • aswu/353/4/19

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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