Status:
COMPLETED
Vaginal Dinoprostone Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System in Women With no Previous Vaginal Delivery
Lead Sponsor:
Cairo University
Conditions:
Intrauterine Device
Eligibility:
FEMALE
18-49 years
Phase:
PHASE4
Brief Summary
To investigate whether vaginal dinoprostone administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces failed insertions, insertion-related complications, and pain in ...
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 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 dinoprostone.
- Women refuse to participate in the study
Key Trial Info
Start Date :
August 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04045548
Start Date
August 10 2019
End Date
January 5 2020
Last Update
January 13 2020
Active Locations (1)
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1
faculty of medicine Cairo university
Cairo, Egypt, 11231