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

Not Applicable

Completed

• Conditions: Hypertensive Disorder of Pregnancy
• Interventions: Behavioral: Remote blood pressure monitoring; Diagnostic Test: NT proBNP assessment

• Registration Number: NCT05631067
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study First Submitted: 2022-09-14
• Study Start: 2022-10-15
• Study First Submitted QC: 2022-11-29
• Study First Posted: 2022-11-30
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-26
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BP monitoring arm	NT proBNP assessment	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.
BP monitoring arm	Remote blood pressure monitoring	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.
Control arm	NT proBNP assessment	Control participants will be adults \>18 years of age with an uncomplicated pregnancy and delivery, and without a diagnosis of HDP.

Primary Outcome Measures

Name	Time	Method
Rate of recruitment	Through study completion at 1 year	Number of participants recruited

Secondary Outcome Measures

Name	Time	Method
Fidelity	2 weeks	10 daily home BP checks per participant during 2-week study period
Retention	2 weeks	Proportion (95% CI) of participants who remained with the home BP monitoring pilot study for the 14-day period

Trial Locations

Locations (1)

University of Abuja Teaching Hospital; 🇳🇬 Gwagwalada, FCT, Nigeria