Clinical Trial

Stress Reactivity and Mother-Infant Cardiovascular Disease Risk

Not Yet Recruiting
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Record status
This record was last updated April 1, 2026 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
Prenatal Mindfulness training (MT) shows promise as a preventive intervention against hypertensive disorders of pregnancy (HDP) and may reduce risk for offspring cardiovascular disease (CVD). One proposed mechanism of MT to reduced CVD risk is improved self-regulation following stress. Perhaps the most crucial contributor to the development of self-regulation in the first year is the psychophysiological coregulatory relationship between mother and infant. However, this self-and co-regulation among women exposed to prenatal MT has not been studied and has yet to be examined in relation to CVD risk. The goal of this proposed project is to evaluate maternal-infant physiological reactivity to and recovery from stress at 6 months postpartum following prenatal MT, and to examine the relationship between these maternal infant stress responses and maternal-infant CVD risk at 12 months postpartum. Using a lab-based stress paradigm and well-validated biomarkers of mother and infant CVD risk, the investigators will assess respiratory sinus arrhythmia and heart rate at 6 months postpartum for 40 mother-infant dyads who have completed either prenatal MT or a usual care arm of an RCT examining MT for women at risk for HDP. The investigators will compare maternal, infant, and dyadic stress responses by treatment arm. Then, cardiac stress responses will be examined as predictors of maternal and infant biomarkers of CVD risk at 12 months postpartum.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-01-28; most recent amendment 2026-03-31.
Trial Details
NCT Number NCT06805799
Lead Sponsor Lifespan
Collaborators: National Institute of General Medical Sciences (NIGMS)
Conditions Maternal Health, Infant Health, Hypertension, Behavioral Medicine, Mindfulness, Psychophysiology, Cardiovascular Diseases, Cardiovascular Diseases Risk
Enrollment 40 participants
Start Date 2026-04-15
Primary Completion 2026-07-31 (estimated)
Study Completion 2026-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-01