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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT03568851
Eligibility Criteria:
MAIN STUDY
Inclusion Criteria:
* 15 through 45 years old
* planning to feeding her infant exclusively the mother's own milk for at least 6 months after delivery
* receiving prenatal care, plan to deliver, and plan to return to UC Davis for the postpartum visit
* 32 weeks gestation or greater at screening
Exclusion Criteria:
* have a multiple gestation pregnancy
* planning to initiate a hormonal contraceptive method at the postpartum visit
At time of delivery hospitalization, a second eligibility verification will occur and women will be excluded if they:
* initiated a hormonal contraceptive method (specifically intrauterine device, implant, depo provera injections) during the delivery hospitalization
* had a hysterectomy
* did not deliver at UC Davis
* are no longer interested in study participation
SUB-STUDY
Inclusion Criteria:
* enrolled in the main study
* within 8 weeks postpartum after delivering a singleton
* currently amenorrheic
* planning to continue breastmilk feeding for up to 6 months after delivery
* planning to avoid pregnancy in the first 6 months after delivery
Exclusion Criteria:
* less than 18 years old
* have a previous history of irregular or anovulatory cycles
* are using a hormonal method of contraception
* are unwilling to comply with study procedures
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
15 Years
Maximum Age:
45 Years
Study:
NCT03568851
Study Brief:
Protocol Section:
NCT03568851