Cardiometabolic Risk in Pregnancy and Postpartum

NCT07420465 | Not Yet Recruiting

• 2 other identifiers: FY25-259GBMF9048
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertensive Disorders of Pregnancy; Postpartum Hypertension; Cardiovascular Disease Risk; High Blood Pressure

Outcome Measures

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.

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

Secondary Outcomes (5)

• Change in Systolic Blood Pressure

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

• Change in Diastolic Blood Pressure

  3 months after birth, and 6 months after birth

• Change in cardiometabolic and vascular biomarkers

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

• Systolic Blood Pressure

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

• Diastolic Blood Pressure

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

Study Arms (2)

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.

Behavioral: Postpartum Cardiovascular Disease (CVD) Risk Reduction Program

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.

Behavioral: Enhanced Postpartum Care

Interventions

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.

Postpartum Cardiovascular Disease (CVD) Risk Reduction Program

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.

Enhanced Postpartum Care

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Biological female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancy
• years and older
• rd 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)

You may not qualify if:

• Multiple births
• Diagnosed CVD or diabetes prior to pregnancy
• Renal or other serious maternal diseases pre-pregnancy

Sponsors & Collaborators

• Forgive Avorgbedor: lead

Study Sites (1)

School of Public Health

Accra, Ghana

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Samuel Dery, PhD

  University of Ghana

  STUDY DIRECTOR

Central Study Contacts

Forgive Avorgbedor, PhD

CONTACT

336-334-5111; f-avorgbedo@uncg.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 19, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 28, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)