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 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT02738892
Eligibility Criteria:
Inclusion Criteria:
Pregnant women ≥15 years will be eligible to participate. Additionally, participants will:
1. Have a completed screening ultrasound with gestational age \< 20 weeks
2. Be HIV-uninfected at enrollment (NB: prior to Protocol Version 4.0 \[3 Nov 2017\] enrolled both HIV-infected and uninfected women)
3. Have a singleton or twin pregnancy with fetal heart tones confirmed by ultrasound
4. Reside within Lusaka with no plans to relocate during the study follow-up period
5. Be willing to provide written, informed consent
6. Be willing to allow their infants to participate in the study
Exclusion criteria:
1. Pregnant women \> 24 weeks' gestation or with screening ultrasound ≥ 16 weeks
2. Infants born to women not enrolled in the study
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
15 Years
Maximum Age:
49 Years
Study:
NCT02738892
Study Brief:
Protocol Section:
NCT02738892