Status:
COMPLETED
Misoprostol With Intrauterine Device Insertion
Lead Sponsor:
Oregon Health and Science University
Conditions:
Contraception
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
The purpose of this study is to see if using misoprostol (a medication that softens the cervix) before placing an intrauterine device for contraception reduces pain in women who have never delivered a...
Detailed Description
The investigators intend to conduct a randomized double blind study at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette. Subjects will be approached only after d...
Eligibility Criteria
Inclusion
- Nulliparous women (defined as those without a history of pregnancy, despite the outcome, beyond 20 weeks gestation)
- Ages 18-45
- Seeking long-term reversible contraception with an intrauterine device (either Mirena or Paraguard) through the OHSU Center for Women's Health and Planned Parenthood of the Columbia Willamette
Exclusion
- Pregnancy occurring less than 6 weeks from time of presentation
- History of prior intrauterine device placement
- History of Mullerian tract anomalies
- History of uterine surgery
- Allergy or intolerance to misoprostol or other prostaglandin
- Pelvic inflammatory disease (current or within the past 3 months)
- Sexually transmitted diseases (current)
- Puerperal or postabortion sepsis (current or within the past 3 months)
- Purulent cervicitis (current)
- Undiagnosed abnormal vaginal bleeding
- Malignancy of the genital tract
- Known uterine anomalies or fibroids distorting the cavity in a way incompatible with intrauterine device insertion
- Allergy to any component of the intrauterine device or Wilson's disease (for copper- containing intrauterine device)
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00613366
Start Date
June 1 2007
End Date
December 1 2010
Last Update
March 15 2013
Active Locations (2)
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1
Planned Parenthood of the Columbia Willamette
Portland, Oregon, United States, 97206
2
Oregon Health & Science University
Portland, Oregon, United States, 97239