Clinical trial NCT05631067: Feasibility and Acceptability of Risk Stratification in the Fourth Trimester to Reduce Maternal Morbidity and Mortality
Official title: Feasibility and Acceptability of Remote Blood Pressure Monitoring and Risk Stratification in the Fourth Trimester to Reduce Maternal Cardiovascular Morbidity and Mortality in Nigeria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertensive Disorder of Pregnancy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Abuja Teaching Hospital
First posted: 2022-11-30
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Rate of recruitment
timeFrame: Through study completion at 1 year
Secondary outcomes:
measure: Fidelity
timeFrame: 2 weeks
measure: Retention
timeFrame: 2 weeks
Other outcomes:
measure: Exploratory Outcome
timeFrame: 2 weeks
measure: Incidence of combined adverse cardiovascular events
timeFrame: 12 weeks
Locations:
city: Gwagwalada
country: Nigeria
facility: University of Abuja Teaching Hospital
state: FCT
Study officials:
affiliation: Washington University School of Medicine
name: Zainab Mahmoud, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Mark D Huffman, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Abuja Teaching Hospital
name: Dike Ojji, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: Kathryn Lindley, MD
role: PRINCIPAL_INVESTIGATOR
References: