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

NCT04499989 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2021-08-09

No results posted yet for this study

Summary

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.

Conditions

  • IUCD Complication

Interventions

DRUG

INH

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

DRUG

Placebo Comparator

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

Sponsors & Collaborators

  • Aswan University Hospital

    lead OTHER

Principal Investigators

  • nahla w Shady, md · Aswan universirty

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-06-30
Completion
2021-08-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04499989 on ClinicalTrials.gov