Hypertensive Disorder of PregnancyNCT05631067
Feasibility and Acceptability of Risk Stratification in the Fourth Trimester to Reduce Maternal Morbidity and Mortality
A study testing Remote blood pressure monitoring and NT proBNP assessment in people with Hypertensive Disorder of Pregnancy, run by Washington University School of Medicine at 1 site in Nigeria.
Trial summary
Hypertensive disorders of pregnancy (HDP) are major causes of maternal morbidity and mortality globally and are associated with peripartum and future cardiovascular disease, including stroke, heart failure, and myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertensive Disorder of Pregnancy
- What is being tested?
- Remote blood pressure monitoring and NT proBNP assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteNigeria
- Study dates
- 15 Oct 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults >18 years of age
- Admitted for delivery
- Clinical diagnosis of HDP (i.e., chronic hypertension, gestational hypertension, preeclampsia, eclampsia, the HELLP syndrome, or chronic hypertension with superimposed preeclampsia)
- Control participants:
- Adults >18 years of age
- Admitted for delivery
- with an uncomplicated pregnancy and delivery
Who cannot join
- Unable to provide consent
- Unable to check blood pressure at home
Trial locations and contacts
1 site in 1 country.
Nigeria1 site
University of Abuja Teaching Hospital
Gwagwalada, Federal Capital Territory
About this study
Official title: Feasibility and Acceptability of Remote Blood Pressure Monitoring and Risk Stratification in the Fourth Trimester to Reduce Maternal Cardiovascular Morbidity and Mortality in Nigeria
Hypertensive disorders of pregnancy (HDP) are major causes of maternal morbidity and mortality globally and are associated with peripartum and future cardiovascular disease, including stroke, heart failure, and myocardial infarction. About 1 out of every 10 maternal deaths in Sub-Saharan Africa are associated with HDP, and most of these deaths are preventable with timely, implementation of evidence-based strategies, including postpartum blood pressure (BP) monitoring, treatment of elevated BP and comprehensive postpartum follow up as recommended by the American College of Obstetricians and Gynecologists (ACOG) and the World Health Organization (WHO).
This study aims to contextualize, implement, and evaluate the feasibility, fidelity, and acceptability of: 1) postpartum remote blood pressure monitoring and 2) NTproBNP testing for postpartum risk stratification in women with HDP at the University of Abuja Teaching Hospital in the Federal Capital Territory of Nigeria
Read the detailed description
Aims:
- To evaluate the feasibility, fidelity, and acceptability of home blood pressure monitoring in postpartum patients (n=90) with HDP. The investigators hypothesize that remote blood pressure monitoring will be feasible, implemented as intended, and acceptable among patients, physicians, and other health care workers to improve awareness and early diagnosis of elevated blood pressures (>140/90 mm Hg) in postpartum patients with HDP.
- To evaluate the association between N Terminal-proBNP (NT-proBNP) levels and short-term cardiovascular outcomes (i.e., all-cause cardiovascular hospital readmission, postpartum pre-eclampsia, hypertensive urgency/emergency, stroke, heart failure/pulmonary edema, seizure and mortality at 12-weeks postpartum) in patients with HDP.
- Conditions
- Hypertensive Disorder of Pregnancy
- Being tested
- Remote blood pressure monitoring, NT proBNP assessment
- Medical subject headings
- Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote blood pressure monitoringBehavioural
Participants will receive a blood pressure monitor to check daily BPs for two weeks post partum
NT proBNP assessmentDiagnostic test
Participants will have biomarker assessment at 0-2 days postpartum
| Study group | Role | What they receive |
|---|---|---|
| BP monitoring arm | Experimental | Participants will be adults >18 years of age admitted for delivery with a diagnosis of HDP (i.e., chronic hypertension, gestational hypertension, preeclampsia, eclampsia, the HELLP syndrome, or chronic hypertension with superimposed preeclampsia) per the American College of Obstetricians and Gynecologists Criteria. Receives: Behavioral: Remote blood pressure monitoring; Diagnostic Test: NT proBNP assessment |
| Control arm | Active comparator | Control participants will be adults >18 years of age with an uncomplicated pregnancy and delivery, and without a diagnosis of HDP. Receives: Diagnostic Test: NT proBNP assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recruitment
Number of participants recruited
Measured: Through study completion at 1 year
Secondary outcomes (2)
Fidelity
10 daily home BP checks per participant during 2-week study period
Measured: 2 weeks
Retention
Proportion (95% CI) of participants who remained with the home BP monitoring pilot study for the 14-day period
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start15 Oct 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Disorder of PregnancyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Abuja Teaching Hospital
- Responsible party
- Principal investigator, Zainab Mahmoud, Washington University School of Medicine
- Investigators
- Zainab Mahmoud, MD, Principal investigator, Washington University School of MedicineMark D Huffman, MD MPH, Principal investigator, Washington University School of MedicineDike Ojji, MBBS PhD, Principal investigator, University of Abuja Teaching HospitalKathryn Lindley, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631067
- Sponsor's protocol ID
- #202207009
- Status last verified
- Nov 2023
- First submitted
- 14 Sep 2022
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available within 1 year of study completion
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Remote Blood Pressure Monitoring and Risk Stratification in the Fourth Trimester to Reduce Maternal Cardiovascular Morbidity and Mortality in Nigeria
- ClinicalTrials.gov ID
- NCT05631067
- Acronym / sponsor ID
- #202207009
- Conditions
- Hypertensive Disorder of Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Abuja Teaching Hospital
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 30 Nov 2022 (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.
Hypertensive disorders of pregnancy (HDP) are major causes of maternal morbidity and mortality globally and are associated with peripartum and future cardiovascular disease, including stroke, heart failure, and myocardial infarction. About 1 out of every 10 maternal deaths in Sub-Saharan Africa are associated with HDP, and most of these deaths are preventable with timely, implementation of evidence-based strategies, including postpartum blood pressure (BP) monitoring, treatment of elevated BP and comprehensive postpartum follow up as recommended by the American College of Obstetricians and Gynecologists (ACOG) and the World Health Organization (WHO).
This study aims to contextualize, implement, and evaluate the feasibility, fidelity, and acceptability of: 1) postpartum remote blood pressure monitoring and 2) NTproBNP testing for postpartum risk stratification in women with HDP at the University of Abuja Teaching Hospital in the Federal Capital Territory of Nigeria
Detailed description
Aims:
- To evaluate the feasibility, fidelity, and acceptability of home blood pressure monitoring in postpartum patients (n=90) with HDP. The investigators hypothesize that remote blood pressure monitoring will be feasible, implemented as intended, and acceptable among patients, physicians, and other health care workers to improve awareness and early diagnosis of elevated blood pressures (>140/90 mm Hg) in postpartum patients with HDP.
- To evaluate the association between N Terminal-proBNP (NT-proBNP) levels and short-term cardiovascular outcomes (i.e., all-cause cardiovascular hospital readmission, postpartum pre-eclampsia, hypertensive urgency/emergency, stroke, heart failure/pulmonary edema, seizure and mortality at 12-weeks postpartum) in patients with HDP.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BP monitoring arm | Experimental | Behavioral: Remote blood pressure monitoring, Diagnostic Test: NT proBNP assessmentParticipants will be adults >18 years of age admitted for delivery with a diagnosis of HDP (i.e., chronic hypertension, gestational hypertension, preeclampsia, eclampsia, the HELLP syndrome, or chronic hypertension with superimposed preeclampsia) per the American College of Obstetricians and Gynecologists Criteria. |
| Control arm | Active comparator | Diagnostic Test: NT proBNP assessmentControl participants will be adults >18 years of age with an uncomplicated pregnancy and delivery, and without a diagnosis of HDP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults >18 years of age
- Admitted for delivery
- Clinical diagnosis of HDP (i.e., chronic hypertension, gestational hypertension, preeclampsia, eclampsia, the HELLP syndrome, or chronic hypertension with superimposed preeclampsia)
- Adults >18 years of age
- Admitted for delivery
Key exclusion criteria (2 listed)
- Unable to provide consent
- Unable to check blood pressure at home
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 |
|---|---|---|
| Remote blood pressure monitoringParticipants will receive a blood pressure monitor to check daily BPs for two weeks post partum | Behavioural | BP monitoring arm |
| NT proBNP assessmentParticipants will have biomarker assessment at 0-2 days postpartum | Diagnostic test | BP monitoring arm, Control arm |
Primary outcome
Rate of recruitment
Time frame: Through study completion at 1 year
Number of participants recruited
2 secondary outcomes
Fidelity
Time frame: 2 weeks
Retention
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: Yes. IPD will be available within 1 year of study completion
Related trials for Hypertensive Disorder of Pregnancy
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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. This study is not recruiting at the moment.
Zainab Mahmoud, MD principal investigator
Washington University School of Medicine
Mark D Huffman, MD MPH principal investigator
Washington University School of Medicine
Dike Ojji, MBBS PhD principal investigator
University of Abuja Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote blood pressure monitoring and NT proBNP assessment in people with Hypertensive Disorder of Pregnancy, run by Washington University School of Medicine at 1 site in Nigeria.
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 7 inclusion and 2 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: finished, as of the sponsor's last update on 28 Nov 2023. 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 Nigeria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recruitment (time frame: Through study completion at 1 year). 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 28 Nov 2023.