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 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT05282368
Eligibility Criteria:
Inclusion Criteria:
* A study participant can include a pregnant person past 20 weeks of pregnancy (this includes a vulnerable population)
* Willing and able to comply with study procedures.
* Participants must be ≥ 18 years old.
* Participants must be able to read, write and speak English.
* Participants must have access, and ability to use a smartphone, tablet, or computer in a private location.
* The pregnant woman/person and her caregiving partner are planning for infant delivery and care.
* The fetal diagnosis of the major anomaly affects the heart (i.e., CCHD). See definition of CCHD included earlier in the protocol. Other anomalies could be present and potentially impair other organs.
* The infant's anomaly will likely require surgical and/or medical intervention within the first year of life.
* The fetus/infant is expected to live with surgical and/or medical intervention (this includes a vulnerable population).
* There may be genetic and/or chromosomal conditions in addition to the heart/structural anomalies
Exclusion Criteria:
* Pregnancy termination
* The fetal anomaly diagnosis is highly likely to result in fetal or infant demise shortly after birth.
* Adults lacking the capacity to consent
* Adults who do not have access to a smart phone, tablet, or device.
* Caregiving partner cannot enroll if mother is not enrolled
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05282368
Study Brief:
Protocol Section:
NCT05282368