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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT06442358
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years old
* Singleton pregnancy
* Gestational age ≥ 24 0/7 weeks
* No known major fetal or genetic anomalies (may include: isolated pyelectasis, isolated --VSD, multicystic dysplastic kidney, cleft lip/palate, club foot, etc.)
* Ability to understand and sign informed consent in English
* Ability to read and understand instructions in English
* Ability to hold an ultrasound probe and respond to clinician instructions
* BMI less than 40 at initial prenatal visit
* Scheduled biophysical profile (BPP)
* Any maternal/pregnancy complications requiring antenatal testing, including but not limited to intrauterine growth restriction, chronic or gestational hypertension, preexisting or gestational diabetes, autoimmune disorder, etc.
Exclusion Criteria:
* Multiple gestation
* Known major fetal structural anomaly or aneuploidy
* Known fetal or genetic anomalies
* Ruptured membranes
* Uterine complaints, such as painful contractions
* Maternal concern for decreased fetal movement
* Not evaluated vaginal bleeding (not including spotting)
* Fetal or maternal criteria that require urgent delivery
* BMI ≥ 40 at initial prenatal visit
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06442358
Study Brief:
Protocol Section:
NCT06442358