Vaginal Dinoprostone Administration Prior to a T380A Intrauterine Device Insertion in Nulliparous Women.

• Status: Completed
• Trial end date: 2019-03-10
• Target enrollment: 0
• Participant gender: Female

Summary

To investigate whether vaginal dinoprostone administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications and pain in nulliparous women.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Treatments: Dinoprostone

Criteria

Inclusion Criteria:

• Nulliparous women aged over 18 years of age requesting a copper IUD for contraception, had a negative pregnancy test.

Exclusion Criteria:

• • a prior pregnancy greater than 20 weeks of duration

• 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 to dinoprostone.