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| ID | Type | Description | Link |
|---|---|---|---|
| GBMF9048 | Other Grant/Funding Number | Gordon and Betty Moore Foundation |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postpartum Cardiovascular Disease (CVD) Risk Reduction Program | Experimental | The participants assigned to the PP-CVD Risk Reduction arm receive 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. |
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| Enhanced Postpartum Care | Active Comparator | The participants assigned to the Enhanced Postpartum Care arm receive 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Postpartum Cardiovascular Disease (CVD) Risk Reduction Program | Behavioral | The 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3 months after birth, and 6 months after birth |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Biological female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Forgive Avorgbedor, PhD | Contact | 336-334-5111 | f-avorgbedo@uncg.edu |
| Name | Affiliation | Role |
|---|---|---|
| Samuel Dery, PhD | University of Ghana | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Public Health | Accra | Ghana |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Enhanced Postpartum Care | Behavioral | The 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. |
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| Baseline, 3 months after birth, and 6 months after birth |
| 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. | 3 months after birth, and 6 months after birth |
| 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. | Baseline, 3 months after birth, and 6 months after birth |
| Systolic Blood Pressure | Systolic blood pressure, expressed in millimeters of mercury (mmHg), is measured using validated automated home blood pressure monitors. | Baseline, 3 months after birth, and 6 months after birth |
| Diastolic Blood Pressure | Diastolic blood pressure, expressed in millimeters of mercury (mmHg), is measured using validated automated home blood pressure monitors. | Baseline, 3 months after birth, and 6 months after birth |