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| Name | Class |
|---|---|
| University of Abuja Teaching Hospital | OTHER |
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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
Aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote blood pressure monitoring | Behavioral | Participants will receive a blood pressure monitor to check daily BPs for two weeks post partum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of recruitment | Number of participants recruited | Through study completion at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Fidelity | 10 daily home BP checks per participant during 2-week study period | 2 weeks |
| Retention | Proportion (95% CI) of participants who remained with the home BP monitoring pilot study for the 14-day period |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Outcome | Detection of elevated BP>140/90 mm Hg Detection of elevated BP>140/90 mm Hg | 2 weeks |
| Incidence of combined adverse cardiovascular events | The incidence of a combined adverse cardiovascular endpoint (all-cause cardiovascular hospital readmission, postpartum pre-eclampsia, hypertensive urgency/emergency, stroke, heart failure/pulmonary edema, seizure and mortality) at 12-weeks postpartum. |
Inclusion Criteria:
Control participants:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zainab Mahmoud, MD | Washington University School of Medicine | Principal Investigator |
| Mark D Huffman, MD MPH | Washington University School of Medicine | Principal Investigator |
| Dike Ojji, MBBS PhD | University of Abuja Teaching Hospital | Principal Investigator |
| Kathryn Lindley, MD | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Abuja Teaching Hospital | Gwagwalada | Federal Capital Territory | Nigeria |
IPD will be available within 1 year of study completion
Data will be available within 1 year of study conclusion
Criteria and URL will be provided
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| NT proBNP assessment | Diagnostic Test | Participants will have biomarker assessment at 0-2 days postpartum |
|
| 2 weeks |
| 12 weeks |
| ID | Term |
|---|---|
| D014115 | Toxemia |
| ID | Term |
|---|---|
| D007239 | Infections |
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