Status:
COMPLETED
Vaginal Isonicotinic Acid Hydrazide Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System
Lead Sponsor:
Aswan University Hospital
Conditions:
IUCD Complication
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
To investigate whether vaginal isonicotinic acid hydrazide (INH) administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces failed insertions, insertion-related compli...
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,...
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 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
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04500028
Start Date
August 1 2020
End Date
December 1 2021
Last Update
May 13 2022
Active Locations (1)
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1
Aswan University Hospital
Aswān, Egypt, 81528