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 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT06741735
Eligibility Criteria:
Inclusion Criteria
* English Speaking
* \> 18 years of age
* Singleton gestation
* Missouri Medicaid as primary insurance (paid by study), offered to patients with private insurance for self-pay
* Requires antenatal testing between 32-40 weeks according to institutional policies
* One of the following indications for fetal NST:
* Gestational diabetes
* Well-controlled type II diabetes
* Chronic hypertension without evidence of placental insufficiency
* Advanced maternal age
* Obesity (as defined as BMI \>30 and \<45)
* Android or iOS system-operated telephone or tablet
* Home or work access to reliable internet (WIFI screening completed by research personnel)
Exclusion Criteria
* Multiple gestations
* Additional co-morbidities not listed in the inclusion criteria
* PPROM or evidence of preterm labor
* Oligohydramnios of \< 5 cm of polyhydramnios \> 30
* Co-existing fetal complications: FGR, placenta or vasa previa, fetal chromosomal or structural anomaly, recent (within a week) fetal testing of a BPP \< 8/10 prior to enrollment
* Intention to transfer care to different provider during the pregnancy
* Currently institutionalized or incarcerated
* Inability to consent for oneself
* \<18 years of age
* History of prior stillbirth
* Lack of access to reliable internet
* Abdominal skin disorder that prevents use of the INVO device
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06741735
Study Brief:
Protocol Section:
NCT06741735