Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2025-12-24 @ 4:30 PM
NCT ID:
NCT00613366
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00613366
Study Brief:
Protocol Section:
NCT00613366