The goal of this interventional study is to learn from patients and healthcare providers at 4 health institutions (study sites) in Abuja and Kano in Nigeria what ways to best develop the content of a Hypertensive Disorders of Pregnancy ( HDP) Management package for pregnant women, and evaluate the effectiveness of implementing this package in improving cardiovascular health of pregnant women. The main question it aims to answer is:
Will a contextualized home BP monitoring program lead to better BP control among patients with HDP in Nigeria?
Postpartum adults (>18 years)
postpartum emancipated minors (in accordance with the Nigerian guidelines for young persons' participation in research and reproductive health services)
with diagnosis of HDP prior to delivery delivered at one of the participating sites able to provide informed consent.
unable to provide consent.
Crossover
Hypertension Disorders of Pregnancy (HDP) Implementation Bundle
Other interventionThe HDP Implementation Bundle will consist of 4 main blocks namely; patient education, home BP monitoring, a contextualized follow-up protocol and provision of free anti-hypertensives if need. Collectively, these will lead to design and development of a contextualized home BP monitoring program.
Between group difference in change in systolic BP from baseline to 6-week follow-up
The change in systolic BP from baseline to 6-week follow-up between the intervention and control group
Between group differences in change in diastolic BP at 6 weeks follow-up and change in both systolic an diastolic BP at 12 weeks
The change in diastolic BP from baseline to 6-week follow-up between the intervention and control groups.
Between group differences in systolic and diastolic BP at 12 weeks follow-up
The change mean systolic and diastolic BPs 12 weeks follow-up between the intervention and control group
Incidence of serious adverse events (eg dizziness) [Safety Outcomes]
Safety outcomes include incidence of serious adverse events (eg dizziness) collected via surveys and patient charts at 6- weeks,12-weeks and 6-months postpartum
Number of eligible patient participants who utilized the HDP Implementation Bundle (Reach)
Number, age, socio-demographics of patients who were enrolled in the HDP Implementation Bundle.
Between-group difference in change in systolic BP from baseline to 6-week follow-up (Effectiveness)
Did the HDP Implementation Bundle impact effectiveness outcomes?
Number of clinical sites where the HDP Implementation Bundle was widely utilized (Adoption)
Records and surveys assessed to establish whether the HDP Implementation Bundle was widely utilized at clinical sites. Patient enrolment in HDP Bundle, where at least 1 home BP measurement is reported among total participants.
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Washington University School of Medicine
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
