Cardiometabolic Risk in Pregnancy and Postpartum

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.

Study Overview

• Status: Not yet recruiting
• Conditions: High Blood Pressure; Cardiovascular Disease Risk; Postpartum Hypertension; Hypertensive Disorders of Pregnancy
• Intervention / Treatment: Behavioral: Postpartum Cardiovascular Disease (CVD) Risk Reduction Program; Behavioral: Enhanced Postpartum Care

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Forgive Avorgbedor, PhD; Phone Number: 336-334-5111; Email: f-avorgbedo@uncg.edu

Study Locations

• Ghana
  • Accra, Ghana
    • School of Public Health
    • Contact: Samuel Dery, PhD; Phone Number: +23344868703; Email: skdery@ug.edu.gh
    • Principal Investigator: Samuel Dery, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Postpartum Cardiovascular Disease (CVD) Risk Reduction Program; 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.	Behavioral: Postpartum 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.
Active Comparator: Enhanced Postpartum Care; 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.	Behavioral: Enhanced 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Forgive Avorgbedor
• Investigators: Study Director: Samuel Dery, PhD, University of Ghana

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): June 28, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: FY25-259; GBMF9048 (Other Grant/Funding Number: Gordon and Betty Moore Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No