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 @ 11:05 PM
Ignite Modification Date:
2025-12-24 @ 11:05 PM
NCT ID:
NCT02169869
Eligibility Criteria:
Inclusion Criteria:
* Female
* 18 yo or older
* Singleton pregnancy at ≥32 weeks gestation at time of enrollment
* Voluntarily requesting either copper T380A or levonorgestrel IUD (LNG-IUS) placement for postpartum contraception
* English or Spanish speaking
* Able to give consent and agree to the terms of the study
* Less than 10 prenatal visits or 2 or more no show visits
* Since IUDs are not on our hospital formulary, the patient must qualify for a Long Acting Reversible Contraceptive (LARC) IUD (this includes all Oregon Health Plan (OHP) or Citizen/Alien Waived Emergent Medical (CAWEM) insured patients or women with income \<300% of the federal poverty line).
Exclusion Criteria:
* Anatomic uterine abnormalities that prevent proper fundal placement of IUD (obstructive myomata, bicornuate, septate, etc)
* Chorioamnionitis (also consider other risk factors such as prolonged rupture of membranes \>18 hours, prolonged labor \>24 hours, fever \>38C)
* Puerperal sepsis
* Unresolved postpartum hemorrhage
* Extensive genital trauma
* Current incarceration
* Known or suspected untreated endocervical gonorrhea, chlamydia
* Wilson's disease, copper allergy (Paragard only)
* Known or suspected cervical or endometrial cancer or pelvic tuberculosis
* Current breast cancer (LNG-IUS only)
* Systemic lupus erythematosus (SLE) with severe thrombocytopenia (Paragard only)
* Trophoblastic disease (benign or malignant)
* AIDS not stable on antiretroviral
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02169869
Study Brief:
Protocol Section:
NCT02169869