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

NCT05631067 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-11-28

No results posted yet for this study

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

Conditions

  • Hypertensive Disorder of Pregnancy

Interventions

BEHAVIORAL

Remote blood pressure monitoring

Participants will receive a blood pressure monitor to check daily BPs for two weeks post partum

DIAGNOSTIC_TEST

NT proBNP assessment

Participants will have biomarker assessment at 0-2 days postpartum

Sponsors & Collaborators

  • University of Abuja Teaching Hospital

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Zainab Mahmoud, MD · Washington University School of Medicine

  • Mark D Huffman, MD MPH · Washington University School of Medicine

  • Dike Ojji, MBBS PhD · University of Abuja Teaching Hospital

  • Kathryn Lindley, MD · Vanderbilt University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-15
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • Nigeria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05631067 on ClinicalTrials.gov