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

NCT05631067 | Completed

• 1 other identifier: #202207009
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertensive Disorder of Pregnancy

Outcome Measures

Primary Outcomes (1)

• Rate of recruitment

  Number of participants recruited

  Through study completion at 1 year

Secondary Outcomes (2)

• Fidelity

  2 weeks

• Retention

  2 weeks

Other Outcomes (2)

• Exploratory Outcome

  2 weeks

• Incidence of combined adverse cardiovascular events

  12 weeks

Study Arms (2)

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.

Behavioral: Remote blood pressure monitoring; Diagnostic Test: NT proBNP assessment

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.

Diagnostic Test: NT proBNP assessment

Interventions

Remote blood pressure monitoring BEHAVIORAL

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

BP monitoring arm

NT proBNP assessment DIAGNOSTIC_TEST

Participants will have biomarker assessment at 0-2 days postpartum

BP monitoring arm; Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to provide consent
• Unable to check blood pressure at home

Sponsors & Collaborators

• Washington University School of Medicine: lead
• University of Abuja Teaching Hospital: collaborator

Study Sites (1)

University of Abuja Teaching Hospital

Gwagwalada, Federal Capital Territory, Nigeria

Location

MeSH Terms

Conditions

Toxemia

Condition Hierarchy (Ancestors)

Infections

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Medicine (Principal Investigator)

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: November 30, 2022
• Study Start: October 15, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available within 1 year of study conclusion
• Access Criteria: Criteria and URL will be provided

Locations

NG (1)