Vaginal Dinoprostone Administration Prior to an Intrauterine Device Insertion in Multiparous Women. (NCT04046302) | Clinical Trial Compass
CompletedPhase 4
Vaginal Dinoprostone Administration Prior to an Intrauterine Device Insertion in Multiparous Women.
Egypt160 participantsStarted 2019-08-30
Plain-language summary
To investigate whether vaginal dinoprostone administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications, and pain in multiparous women.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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Inclusion Criteria:
* multiparous women aged over 18 years of age requesting an IUD for contraception, had a negative pregnancy test.
Exclusion Criteria:
* 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.
What they're measuring
1
the difference in the pain intensity scores between the study groups