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 @ 12:47 PM
Ignite Modification Date:
2025-12-24 @ 12:47 PM
NCT ID:
NCT01175161
Eligibility Criteria:
Inclusion Criteria:
* Primary Inclusion Criteria:
* Ages 18-45 attending prenatal care
* Greater than 34 weeks estimated gestational age
* Desire to use the CuT380A-IUCD for contraception postpartum
* Plan to stay in the area for at least 5 months postpartum
* If HIV+ the women must be WHO Clinical Stage 1 or 2, or known to be clinically well on antiretroviral therapy as documented in their health passport
* No prior cesarean delivery
* No treatment for pelvic inflammatory disease within 3 months prior to pregnancy
* No known uterine anomalies
* No known pelvic tuberculosis
* No known genital tract cancer
* No known allergy to copper
* No known history of ectopic pregnancy within 3 months prior to pregnancy.
* No evidence of clinical anemia as assessed by a clinician at enrollment
* Any other condition a clinician feels should preclude the woman from receiving the IUCD 10-minutes to 48 hours after delivery
Secondary Eligibility Criteria
* Vaginal delivery within the last 48 hours
* No postpartum hemorrhage documented by the delivering clinician
* Not known to have ruptured membranes for greater than 24 hours prior to delivery
* No infection diagnosed by a clinician
* No fever of greater than 38° during labour or delivery
* Any other condition which a clinician feels precludes the woman from receiving the IUCD 10 minutes to 48 hours after delivery.
Exclusion Criteria:
* prior cesarean section
* fever during labor and delivery
* AIDS, not well on antiretroviral therapy
* genital tuberculosis
* known uterine abnormalities or genital tract cancer
* history of ectopic pregnancy within 3 months of current pregnancy
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01175161
Study Brief:
Protocol Section:
NCT01175161