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Clinical Trials/NCT05631067
NCT05631067
Completed
Not Applicable

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

Washington University School of Medicine1 site in 1 country180 target enrollmentOctober 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertensive Disorder of Pregnancy
Sponsor
Washington University School of Medicine
Enrollment
180
Locations
1
Primary Endpoint
Rate of recruitment
Status
Completed
Last Updated
2 years ago

Overview

Brief 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. 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: 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.

Registry
clinicaltrials.gov
Start Date
October 15, 2022
End Date
June 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zainab Mahmoud

Instructor of Medicine (Principal Investigator)

Washington University School of Medicine

Eligibility Criteria

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

Outcomes

Primary Outcomes

Rate of recruitment

Time Frame: Through study completion at 1 year

Number of participants recruited

Secondary Outcomes

  • Fidelity(2 weeks)
  • Retention(2 weeks)

Study Sites (1)

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