Feasibility and Acceptability of Risk Stratification in the Fourth Trimester to Reduce Maternal Morbidity and Mortality
NCT ID: NCT05631067
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2022-10-15
2023-06-30
Brief Summary
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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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1. 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.
2. 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
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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BP monitoring arm
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.
Remote blood pressure monitoring
Participants will receive a blood pressure monitor to check daily BPs for two weeks post partum
NT proBNP assessment
Participants will have biomarker assessment at 0-2 days postpartum
Control arm
Control participants will be adults \>18 years of age with an uncomplicated pregnancy and delivery, and without a diagnosis of HDP.
NT proBNP assessment
Participants will have biomarker assessment at 0-2 days postpartum
Interventions
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Remote blood pressure monitoring
Participants will receive a blood pressure monitor to check daily BPs for two weeks post partum
NT proBNP assessment
Participants will have biomarker assessment at 0-2 days postpartum
Eligibility Criteria
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Inclusion Criteria
* 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 check blood pressure at home
18 Years
FEMALE
Yes
Sponsors
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University of Abuja Teaching Hospital
OTHER
Washington University School of Medicine
OTHER
Responsible Party
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Zainab Mahmoud
Instructor of Medicine (Principal Investigator)
Principal Investigators
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Zainab Mahmoud, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Mark D Huffman, MD MPH
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Dike Ojji, MBBS PhD
Role: PRINCIPAL_INVESTIGATOR
University of Abuja Teaching Hospital
Kathryn Lindley, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University
Locations
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University of Abuja Teaching Hospital
Gwagwalada, Federal Capital Territory, Nigeria
Countries
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Other Identifiers
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#202207009
Identifier Type: -
Identifier Source: org_study_id