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

Hypertensive Disorder of Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05631067
• Other study ID #: #202207009
• Status: Completed
• Phase: N/A
• Start date: October 15, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertensive Disorder of Pregnancy
• Toxemia

Intervention

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

Locations

Country	Name	City	State
Nigeria	University of Abuja Teaching Hospital	Gwagwalada	FCT

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	University of Abuja Teaching Hospital

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Outcome	Detection of elevated BP>140/90 mm Hg; Detection of elevated BP>140/90 mm Hg	2 weeks
Other	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
Primary	Rate of recruitment	Number of participants recruited	Through study completion at 1 year
Secondary	Fidelity	10 daily home BP checks per participant during 2-week study period	2 weeks
Secondary	Retention	Proportion (95% CI) of participants who remained with the home BP monitoring pilot study for the 14-day period	2 weeks