Status:

COMPLETED

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

Lead Sponsor:

Aswan University Hospital

Conditions:

IUCD Complication

Eligibility:

FEMALE

18-45 years

Phase:

PHASE4

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 Deliv...

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 co...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2021

Estimated Enrollment :

220 Patients enrolled

Trial Details

Trial ID

NCT04499989

Start Date

September 1 2020

End Date

August 1 2021

Last Update

August 9 2021

Active Locations (1)

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1

Aswan University Hospital

Aswān, Egypt, 81528