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NCT Number: NCT05631067

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

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

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Key information

Conditions

Hypertensive Disorder of Pregnancy Infections Toxemia

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Abuja Teaching Hospital

Gwagwalada, Federal Capital Territory, Nigeria

About this study

Aims:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote blood pressure monitoring

Behavioral

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

NT proBNP assessment

Diagnostic Test

Participants will have biomarker assessment at 0-2 days postpartum

Primary outcomes

  1. Rate of recruitment

    Time frame: Through study completion at 1 year

    Number of participants recruited

Secondary outcomes

  1. Fidelity

    Time frame: 2 weeks

    10 daily home BP checks per participant during 2-week study period

  2. Retention

    Time frame: 2 weeks

    Proportion (95% CI) of participants who remained with the home BP monitoring pilot study for the 14-day period

Other outcomes

  1. Exploratory Outcome

    Time frame: 2 weeks

    Detection of elevated BP>140/90 mm Hg

    Detection of elevated BP>140/90 mm Hg

  2. Incidence of combined adverse cardiovascular events

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • University of Abuja Teaching Hospital

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 30, 2022
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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