Status:
COMPLETED
Vaginal Dinoprostone Administration Prior to an Intrauterine Device Insertion in Multiparous Women.
Lead Sponsor:
Cairo University
Conditions:
IUD Insertion
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
Brief Summary
To investigate whether vaginal dinoprostone administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications, and pain in multiparous women.
Detailed Description
Women may experience pain and technical difficulties may be encountered when insertion of an intrauterine device (IUD) is attempted through a narrow cervical canal.IUD insertion- related complications ...
Eligibility Criteria
Inclusion
- multiparous women aged over 18 years of age requesting an IUD for contraception, had a negative pregnancy test.
Exclusion
- currently pregnant or were pregnant within 6 weeks of study entry
- had a prior attempted or successful IUD insertion
- had a history of a cervical procedure such as cone biopsy, Loop electrosurgical excision procedure, or cryotherapy
- any World Health Organization Medical Eligibility Criteria category 3 or 4 precaution to an IUD
- active vaginitis or cervicitis
- undiagnosed abnormal uterine bleeding
- pelvic inflammatory disease within the last 3 months
- fibroids or other uterine abnormalities distorting the uterine cavity
- contraindication or allergy to dinoprostone.
Key Trial Info
Start Date :
August 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2020
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04046302
Start Date
August 30 2019
End Date
January 30 2020
Last Update
March 10 2020
Active Locations (1)
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1
faculty of medicine Cairo university
Giza, Egypt, 11231