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

NCT ID: NCT04499989

Last Updated: 2021-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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IUCD Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double blind randomized trial
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
double blind randomized trial

Study Groups

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INH

3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion.

Group Type EXPERIMENTAL

INH

Intervention Type DRUG

3 vaginal tablet of isonicotinic acid hydrazide self inserted 12 hours before IUD insertion.

Placebo Comparator

3 vaginal tablet of Placebo Comparator self-inserted by the patient 12 hours before IUD insertion.

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

3 vaginal tablet of Placebo Comparator self inserted 12 hours before IUD insertion

Interventions

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INH

3 vaginal tablet of isonicotinic acid hydrazide self inserted 12 hours before IUD insertion.

Intervention Type DRUG

Placebo Comparator

3 vaginal tablet of Placebo Comparator self inserted 12 hours before IUD insertion

Intervention Type DRUG

Other Intervention Names

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isonicotinic acid hydrazide

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aswan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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hany farouk

A Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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nahla w Shady, md

Role: STUDY_CHAIR

Aswan universirty

Locations

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Aswan University Hospital

Aswān, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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aswu/353/4/19

Identifier Type: -

Identifier Source: org_study_id

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