Status:
TERMINATED
Intra Uterine Device Insertion in Nulliparous Women
Lead Sponsor:
University of Colorado, Denver
Conditions:
Contraception
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Over the last several years, more and more women are choosing intrauterine contraception (IUDs) to meet their birth control needs. The effectiveness of IUDs is very similar to tubal sterilization, wit...
Detailed Description
Hypothesis: The prostaglandin E1 analog misoprostol will ease insertion of intrauterine contraceptive devices in nulliparous women. Specific Aim 1: To evaluate the ability to place an IUD in the stan...
Eligibility Criteria
Inclusion
- Desires IUD placement
- 18 years old or older
- negative pregnancy test
- no prior pregnancies beyond 14 6/7 weeks
- no pelvic inflammatory disease (PID) in last 3 months
- no current cervicitis
- no contraindications to IUD insertion (see exclusion criteria below)
- willing to follow-up in 6-8 weeks for a standard IUD follow-up visit
- Determined by her clinician to be an appropriate candidate for an IUD.
Exclusion
- Active cervical infection
- current pregnancy
- prior pregnancy beyond 15 weeks' gestation
- uterine anomaly
- fibroid uterus
- copper allergy/Wilson's disease (for Paragard)
- undiagnosed abnormal uterine bleeding
- cervical or uterine cancer
- allergy to misoprostol (study drug)
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01422226
Start Date
July 1 2011
End Date
August 1 2012
Last Update
February 2 2017
Active Locations (1)
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1
University of Colorado Hopspital, The Children's Hospital
Aurora, Colorado, United States, 80045