Hypertensive Disorder of Pregnancy
Conditions
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.
Interventions
BEHAVIORALRemote blood pressure monitoring
Participants will receive a blood pressure monitor to check daily BPs for two weeks post partum
DIAGNOSTIC_TESTNT proBNP assessment
Participants will have biomarker assessment at 0-2 days postpartum
Sponsors
University of Abuja Teaching Hospital
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of recruitment | Through study completion at 1 year | Number of participants recruited |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Outcome | 2 weeks | Detection of elevated BP\>140/90 mm Hg Detection of elevated BP\>140/90 mm Hg |
| Incidence of combined adverse cardiovascular events | 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. |
Countries
Nigeria
Outcome results
None listed