About this trial
The goal of this study is to evaluate changes in blood pressure and early cardiovascular risk markers and to determine whether a postpartum education intervention can improve cardiovascular risk monitoring among pregnant women in their third trimester through six months postpartum in Accra, Ghana. The study includes women aged 18 years and older with and without pregnancy-related cardiometabolic complications. Findings from this study will inform the development of scalable postpartum screening and intervention strategies to reduce long-term cardiovascular disease risk among women.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Singleton pregnancy
18 years and older
3rd trimester of pregnancy at enrollment
Will be living in the area for the study duration
Disqualifiers
Multiple births
Diagnosed CVD or diabetes prior to pregnancy
Renal or other serious maternal diseases pre-pregnancy
Trial design
Parallel
Treatments tested in this trial
Postpartum Cardiovascular Disease (CVD) Risk Reduction Program
BehavioralThe PP-CVD Risk Reduction Program is a structured cardiovascular disease risk-reduction program that includes home blood pressure monitoring and weekly postpartum education sessions on heart health after pregnancy, nutrition, physical activity, stress management, sleep, weight management, medication adherence, and long-term cardiovascular health for postpartum women.
Enhanced Postpartum Care
BehavioralThe Enhanced Postpartum Care intervention is a structured postpartum support program that includes home blood pressure monitoring and scheduled maternal-infant health check-ins, providing education on postpartum recovery, infant care, mental health, nutrition, infection prevention, and family planning to support maternal health during the postpartum period.
Treatment groups
Trial outcomes
Primary outcomes
Change in Carotid-Femoral Pulse Wave Velocity (PWV)
Change in arterial stiffness measured as carotid-femoral pulse wave velocity (PWV), expressed in meters per second (m/s), assessed using the Vicorder® system, defined as the difference in PWV measured during baseline, 3 months after birth, and 6 months after birth.
Secondary outcomes
Change in Systolic Blood Pressure
Change in systolic blood pressure, expressed in millimeters of mercury (mmHg), measured using validated automated home blood pressure monitors. Participants will self-measure systolic blood pressure at baseline (third trimester of pregnancy), 3 months, and 6 months postpartum, with change defined as the difference in systolic blood pressure across these time points to characterize postpartum blood pressure trajectories and compare intervention groups.
Change in Diastolic Blood Pressure
Change in diastolic blood pressure, expressed in millimeters of mercury (mmHg), measured using validated automated home blood pressure monitors. Participants will self-measure diastolic blood pressure at baseline (third trimester of pregnancy), 3 months, and 6 months postpartum, with change defined as the difference in diastolic blood pressure across these time points to characterize postpartum blood pressure trajectories and compare intervention groups.
Change in cardiometabolic and vascular biomarkers
Cardiometabolic, inflammatory, and vascular biomarkers (e.g., soluble Fms-like tyrosine kinase-1 \[sFlt-1\]) will be measured from fasting blood samples.
Systolic Blood Pressure
Systolic blood pressure, expressed in millimeters of mercury (mmHg), is measured using validated automated home blood pressure monitors.
Sponsors and contacts
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Forgive Avorgbedor
Lead sponsor
University of North Carolina, Greensboro
Sponsor institution