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NCT Number: NCT07420465

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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

School of Public Health

Accra, Ghana

Location status: Recruiting

Location contact

Samuel Dery, PhD

CONTACT

[email protected]

+23344868703

Samuel Dery, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Carotid-Femoral Pulse Wave Velocity (PWV)

    Time frame: 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 outcomes

  1. Change in Systolic Blood Pressure

    Time frame: 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.

  2. Change in Diastolic Blood Pressure

    Time frame: 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.

  3. Change in cardiometabolic and vascular biomarkers

    Time frame: 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.

  4. Systolic Blood Pressure

    Time frame: 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.

  5. Diastolic Blood Pressure

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Forgive Avorgbedor, PhD

CONTACT

[email protected]

336-334-5111

Sponsors and collaborators

Lead sponsor

Forgive Avorgbedor

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 19, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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