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 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT04700059
Eligibility Criteria:
Inclusion Criteria:
* All subjects must be able to read and write Spanish.
* RCT will be limited to pregnant adolescents who are between the ages of 14-19 years and 12-34 weeks gestational age. Other caregivers (age 14 years or older) will be eligible if they are planning to be involved in infant care.
* Only pregnant adolescents receiving outpatient prenatal care at INMP or San Bartolomé will be approached as potential participants.
* Only pregnant adolescents who have been cleared by their attending doctor/nurse to engage in the approach/recruitment and interview procedure will be approached as potential participants.
* All infants born to adolescents enrolled during pregnancy will be eligible to be enrolled after birth.
Exclusion Criteria:
* Anyone unable to read and write Spanish.
* Any pregnant adolescent known to have a severe fetal anomaly will not be approached.
* Infants who are advised not to participate by their attending doctor or pediatrician.
* Children or adolescents who are wards of the state will not be enrolled.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT04700059
Study Brief:
Protocol Section:
NCT04700059