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:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT05916534
Eligibility Criteria:
Inclusion Criteria:
* Eligible participants for the pilot RCT will be patients
* aged 18-49 years (childbearing age)
* residing in a Central Brooklyn zip code
* self-reporting as Black,
* who speak English or Haitian Creole, and
* plan to deliver or present for delivery at University Hospital at Downstate (UHD).
* In NYC, SMM increases incrementally with later entry into prenatal care (1st trimester: 208/10,000 deliveries; 2nd trimester: 252/10,000; 3rd trimester: 297/10,000; None: 575/10,000). 3 Accordingly, in order to capture the full range of SMM risk profiles for our pilot study, any pregnant patient/client visiting our clinics will be eligible for enrollment from 13 weeks gestation through delivery, thus allowing follow-up to 3 months post-partum within the 2-year study timeline.
Exclusion Criteria:
* Patients planning to move outside of New York City in the ensuing 3 months post-partum
* Patients demonstrating an impairment that limits their ability to provide informed consent.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT05916534
Study Brief:
Protocol Section:
NCT05916534