Vaginal Isonicotinic Acid Hydrazide Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System

Sponsor

Aswan University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04500028

Collaborator

(none)

220

Enrollment

Location

Arms

Actual Duration (Months)

13.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
IUCD Complication	Drug: INH Drug: Placebo Comparator	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

double blind randomized controlled trialdouble blind randomized controlled trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

double blind randomized controlled trial

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 1, 2020

Actual Primary Completion Date :

Oct 31, 2021

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: INH 3 vaginal tablet of isonicotinic acid hydrazide (900mg) ( inserted by the study nurse 4 hours before IUD insertion.	Drug: INH 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.	Drug: Placebo Comparator 3 tablet of placebo inserted by the study nurse 4 hours before IUD insertion.

Arm

Intervention/Treatment

Experimental: INH

3 vaginal tablet of isonicotinic acid hydrazide (900mg) ( inserted by the study nurse 4 hours before IUD insertion.

Drug: INH

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.

Drug: Placebo Comparator

3 tablet of placebo inserted by the study nurse 4 hours before IUD insertion.

Outcome Measures

Primary Outcome Measures

The difference in pain scores during intrauterine device insertion [10 minutes]
The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10

Secondary Outcome Measures

duration of IUD insertion [10 minutes]
duration of IUD insertion measured in minutes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aswan University Hospital	Aswan		Egypt	81528

Sponsors and Collaborators

Aswan University Hospital

Investigators

Study Chair: nahla w Shady, md, Aswan universirty

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

hany farouk, A Professor, Aswan University Hospital

ClinicalTrials.gov Identifier:

NCT04500028

Other Study ID Numbers:

aswu/355/3/19

First Posted:

Aug 5, 2020

Last Update Posted:

May 13, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 13, 2022