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

NCT04499989 | Completed Phase 4 DMC

• 1 other identifier: aswu/353/4/19
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• the difference in the pain intensity scores between the study groups

  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 Outcomes (2)

• Provider ease of insertion

  10 minutes

• insertion time

  10 minutes

Study Arms (2)

INH

EXPERIMENTAL

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

Drug: INH

Placebo Comparator

PLACEBO COMPARATOR

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

Drug: Placebo Comparator

Interventions

INH DRUG

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

Also known as: isonicotinic acid hydrazide

INH

Placebo Comparator DRUG

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

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women Delivered Only by Elective Cesarean Section
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

Location

MeSH Terms

Interventions

Isoniazid

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• nahla w Shady, md

  Aswan universirty

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind randomized trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A Professor

Model Details: double blind randomized trial

Study Record Dates

• First Submitted: August 2, 2020
• First Posted: August 5, 2020
• Study Start: September 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: August 1, 2021
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)