Feasibility and Acceptability of Risk Stratification in the Fourth Trimester to Reduce Maternal Morbidity and Mortality

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Feasibility and Acceptability of Remote Blood Pressure Monitoring and Risk Stratification in the Fourth Trimester to Reduce Maternal Cardiovascular Morbidity and Mortality in Nigeria

Conditions
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Hypertensive Disorder of Pregnancy

Intervention / Treatment
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* Behavioral: Remote blood pressure monitoring
* Diagnostic Test: NT proBNP assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Unable to provide consent Unable to check blood pressure at home

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BP monitoring arm<br>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. | Behavioral: Remote blood pressure monitoring<br>* Participants will receive a blood pressure monitor to check daily BPs for two weeks post partum<br>Diagnostic Test: NT proBNP assessment<br>* Participants will have biomarker assessment at 0-2 days postpartum<br>|
| Active Comparator: Control arm<br>Control participants will be adults >18 years of age with an uncomplicated pregnancy and delivery, and without a diagnosis of HDP. | Diagnostic Test: NT proBNP assessment<br>* Participants will have biomarker assessment at 0-2 days postpartum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of recruitment | Number of participants recruited | Through study completion at 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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 | 2 weeks |