Cardiometabolic Risk in Pregnancy and Postpartum

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorForgive Avorgbedor

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Postpartum Cardiovascular Disease (CVD) Risk Reduction ProgramExperimental treatment 1 intervention
Group B: Enhanced Postpartum CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 3 months after birth, and 6 months after birth

Secondary outcomes

1

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.

Time frame
Baseline, 3 months after birth, and 6 months after birth
2

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.

Time frame
3 months after birth, and 6 months after birth
3

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.

Time frame
Baseline, 3 months after birth, and 6 months after birth
4

Systolic Blood Pressure

Systolic blood pressure, expressed in millimeters of mercury (mmHg), is measured using validated automated home blood pressure monitors.

Time frame
Baseline, 3 months after birth, and 6 months after birth

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Forgive Avorgbedor

Lead sponsor

University of North Carolina, Greensboro

Sponsor institution