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Recruiting NCT07420465

Cardiometabolic Risk in Pregnancy and Postpartum

No phase Interventional Hypertensive Disorders of Pregnancy Postpartum Hypertension Cardiovascular Disease Risk High Blood Pressure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Postpartum Cardiovascular Disease (CVD) Risk Reduction Program, Enhanced Postpartum Care.
Who it may be relevant to
Registry conditions: Hypertensive Disorders of Pregnancy, Postpartum Hypertension, Cardiovascular Disease Risk, High Blood Pressure. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Ghana
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • 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.
  • 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.

Primary outcome measures

  • Change in Carotid-Femoral Pulse Wave Velocity (PWV) [Time frame: Baseline, 3 months after birth, and 6 months after birth]
Secondary outcome measures (5)
  • Change in Systolic Blood Pressure [Time frame: Baseline, 3 months after birth, and 6 months after birth]
  • Change in Diastolic Blood Pressure [Time frame: 3 months after birth, and 6 months after birth]
  • Change in cardiometabolic and vascular biomarkers [Time frame: Baseline, 3 months after birth, and 6 months after birth]
  • Systolic Blood Pressure [Time frame: Baseline, 3 months after birth, and 6 months after birth]
  • Diastolic Blood Pressure [Time frame: Baseline, 3 months after birth, and 6 months after birth]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Ghana · 1 center
  • School of Public Health — Accra

Identifiers

NCT: NCT07420465 · FY25-259 · GBMF9048

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗