Hypertensive Disorders of PregnancyNCT07420465
Cardiometabolic Risk in Pregnancy and Postpartum
A study testing Postpartum Cardiovascular Disease (CVD) Risk Reduction Program and Enhanced Postpartum Care in people with Hypertensive Disorders of Pregnancy and Postpartum Hypertension, run by Forgive Avorgbedor at 1 site in Ghana.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertensive Disorders of Pregnancy, Postpartum Hypertension, Cardiovascular Disease Risk
- What is being tested?
- Postpartum Cardiovascular Disease (CVD) Risk Reduction Program and Enhanced Postpartum Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGhana
- Study dates
- 1 Apr 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- Multiple births
- Diagnosed CVD or diabetes prior to pregnancy
- Renal or other serious maternal diseases pre-pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ghana1 site, 1 recruiting
- Recruiting
School of Public Health
Accra
Samuel Dery, PhD, +23344868703, skdery@ug.edu.gh
Samuel Dery, PhD
About this study
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
- Being tested
- Postpartum Cardiovascular Disease (CVD) Risk Reduction Program, Enhanced Postpartum Care
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postpartum Cardiovascular Disease (CVD) Risk Reduction ProgramBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Enhanced Postpartum Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months after birth, and 6 months after birth
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months after birth, and 6 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Apr 2026
- Primary completion28 Jun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Disorders of PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Forgive Avorgbedor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Forgive Avorgbedor, University of North Carolina, Greensboro
- Investigators
- Samuel Dery, PhD, Study director, University of Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420465
- Sponsor's protocol ID
- FY25-259
- Other IDs
- GBMF9048
- Status last verified
- Jul 2026
- First submitted
- 4 Feb 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Risk in Pregnancy and Postpartum
- ClinicalTrials.gov ID
- NCT07420465
- Acronym / sponsor ID
- FY25-259
- Conditions
- Hypertensive Disorders of Pregnancy, Postpartum Hypertension, Cardiovascular Disease Risk, High Blood Pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Forgive AvorgbedorUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 28 Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postpartum Cardiovascular Disease (CVD) Risk Reduction Program | Experimental | Behavioral: Postpartum Cardiovascular Disease (CVD) Risk Reduction ProgramThe 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. |
| Enhanced Postpartum Care | Active comparator | Behavioral: Enhanced Postpartum CareThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- Multiple births
- Diagnosed CVD or diabetes prior to pregnancy
- Renal or other serious maternal diseases pre-pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postpartum Cardiovascular Disease (CVD) Risk Reduction ProgramThe 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. | Behavioural | Postpartum Cardiovascular Disease (CVD) Risk Reduction Program |
| Enhanced Postpartum CareThe 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. | Behavioural | Enhanced Postpartum Care |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samuel Dery, PhD study director
University of Ghana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postpartum Cardiovascular Disease (CVD) Risk Reduction Program and Enhanced Postpartum Care in people with Hypertensive Disorders of Pregnancy and Postpartum Hypertension, run by Forgive Avorgbedor at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Forgive Avorgbedor, PhD (336-334-5111, f-avorgbedo@uncg.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Carotid-Femoral Pulse Wave Velocity (PWV) (time frame: Baseline, 3 months after birth, and 6 months after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.