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 @ 11:58 AM
Ignite Modification Date:
2025-12-24 @ 11:58 AM
NCT ID:
NCT03615261
Eligibility Criteria:
Inclusion Criteria:
* 10-18 weeks gestation
* singleton pregnancy
* receiving prenatal care from a Northwestern University prenatal care clinic \& planning to deliver at Northwestern Hospitals
* English-speaking
* must own a smartphone
* must be willing to receive text messages and respond to short online surveys using their smartphone
* must also agree to wear a wireless adhesive sensor daily
* must have WiFi internet access for the duration of their participation in the study
Exclusion Criteria:
* have known chronic medical or pregnancy complications that may place their infant at risk for neurological disorders (e.g., HIV; acute cytomegalovirus infection (CMV); toxoplasmosis; zika virus; Phenylketonuria (PKU); chromosomal anomalies; metabolic disorder; substance use disorders)
* have significant mental health disorders (e.g., schizophrenia, bipolar disorder, psychosis) which could interfere with study adherence
* unable to wear the BioStamp Sensor due to known skin sensitivity (e.g., allergy to adhesives or silicone), current skin irritation, or broken skin at the placement site
* pacemaker or other sensitive medical device
* unable to provide informed consent, complete MB sessions, or complete study assessments in English
* currently participating in another MB course at the time of recruitment
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03615261
Study Brief:
Protocol Section:
NCT03615261