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

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

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

Study Overview

• Status: Completed
• Conditions: Hypertensive Disorder of Pregnancy
• Intervention / Treatment: Behavioral: Remote blood pressure monitoring; Diagnostic test: NT proBNP assessment

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • FCT
    • Gwagwalada, FCT, Nigeria
      • University of Abuja Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Active Comparator: Control arm; 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; Participants will have biomarker assessment at 0-2 days postpartum

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Outcome	Detection of elevated BP>140/90 mm Hg Detection of elevated BP>140/90 mm Hg	2 weeks
Incidence of combined adverse cardiovascular events	The incidence of a combined adverse cardiovascular endpoint (all-cause cardiovascular hospital readmission, postpartum pre-eclampsia, hypertensive urgency/emergency, stroke, heart failure/pulmonary edema, seizure and mortality) at 12-weeks postpartum.	12 weeks

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: University of Abuja Teaching Hospital
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 26, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Infections; Toxemia; Hypertension
• Other Study ID Numbers: #202207009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be available within 1 year of study completion
• IPD Sharing Time Frame: Data will be available within 1 year of study conclusion
• IPD Sharing Access Criteria: Criteria and URL will be provided
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No