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 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT06557005
Eligibility Criteria:
Inclusion Criteria
* Receiving obstetric care at an MGH-affiliated obstetrics practice (except for the MGH HOPE Clinic, which has a unique care model that provides prenatal and postnatal care for individuals with substance use disorder, including the provision of primary care through 2+ years postpartum)
* Pregnant with a live fetus or delivered a live-born neonate ≥24 weeks of gestation, based on the clinical estimate of gestational age
* If postpartum, has a neonate that is currently living at the time of enrollment
* Has one or more of the following conditions listed in the "Problem List," "Medical History," or clinical notes during prenatal, intrapartum, or postpartum encounters in the EHR (or in the case of BMI, the patient's anthropometric measurements):
* Chronic or essential hypertension
* Hypertensive disorders related to pregnancy (e.g., pre-eclampsia)
* Type 1 or 2 diabetes (i.e., pre-existing diabetes)
* Gestational diabetes
* Class II Obesity (pre-pregnancy body mass index ≥35 kg/m2; or if pre-pregnancy body mass index is not known, a first trimester BMI of ≥35 kg/m2)
* Depression or anxiety disorder
* Has a primary care clinician listed in the patient's medical record
* Has access to or agrees to be enrolled in the electronic health record patient portal and consents to be contacted via these modalities
* Able to read/speak English or Spanish language
* Is age ≥18 years old
Exclusion Criteria
• Any individual not meeting all inclusion criteria
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06557005
Study Brief:
Protocol Section:
NCT06557005