Cardiovascular Disease Risk, High Blood Pressure, Hypertensive Disorders of Pregnancy, Postpartum Hypertension
Conditions
Brief summary
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.
Interventions
BEHAVIORALPostpartum Cardiovascular Disease (CVD) Risk Reduction Program
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.
BEHAVIORALEnhanced Postpartum Care
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.
Sponsors
Forgive Avorgbedor
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Singleton pregnancy * 18 years and older * 3rd trimester of pregnancy at enrollment * Will be living in the area for the study duration * Women with or without pregnancy complications (e.g., gestational hypertension, preeclampsia, gestational diabetes)
Exclusion criteria
* Multiple births * Diagnosed CVD or diabetes prior to pregnancy * Renal or other serious maternal diseases pre-pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Carotid-Femoral Pulse Wave Velocity (PWV) | Baseline, 3 months after birth, and 6 months after birth | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure | Baseline, 3 months after birth, and 6 months after birth | 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 | 3 months after birth, and 6 months after birth | 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 | Baseline, 3 months after birth, and 6 months after birth | 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 | Baseline, 3 months after birth, and 6 months after birth | Systolic blood pressure, expressed in millimeters of mercury (mmHg), is measured using validated automated home blood pressure monitors. |
| Diastolic Blood Pressure | Baseline, 3 months after birth, and 6 months after birth | Diastolic blood pressure, expressed in millimeters of mercury (mmHg), is measured using validated automated home blood pressure monitors. |
Countries
Ghana
Contacts
CONTACTForgive Avorgbedor, PhD
STUDY_DIRECTORSamuel Dery, PhD
University of Ghana
Outcome results
None listed