Clinical trial NCT06859359: Improving Maternal Cardiovascular Outcomes Through the Implementation of a Hypertensive Disorders of Pregnancy Bundle in Nigeria
Official title: Improving Maternal Cardiovascular Outcomes Through the Implementation of a Hypertensive Disorders of Pregnancy Bundle in Nigeria
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertensive Disorder of Pregnancy
Keywords: Hypertension
Pregnancy
Preeclampsia
HDP
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-03-05
Enrollment: 1200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Type 1 hybrid stepped-wedge cluster randomized trial to assess if the utilization of the HDP Implementation Bundle will improve postpartum BP among women with HDP in Nigeria. Randomization will be done at cluster level and sites will begin in control and cross over to intervention phase
Primary purpose: OTHER

Brief summary: 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?

Detailed description: This study aims to contextualize, implement, and evaluate the feasibility, fidelity, and acceptability and effectiveness of: 1) postpartum remote blood pressure monitoring, 2) patient education, 3) development of a standardized postpartum follow-up protocol, and 4) provision of free and/or subsidized antihypertensive medications for patients with HDP in University of Abuja, Murtala Muhammad Specialist Hospital, National Hospital, Abuja and Aminu Kano Teaching Hospital all in Nigeria. These components collectively make up a contextualized postpartum BP monitoring program called the HDP Implementation Bundle. The long-term objective is to implement a contextualized and acceptable evidence-based postpartum home BP monitoring program with supporting services and components, at 4 tertiary care institutions in Nigeria, to improve postpartum BP control in patients with HDP using a multilevel approach.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* unable to provide consent.

Primary outcomes:
measure: Between group difference in change in systolic BP from baseline to 6-week follow-up
timeFrame: Baseline to 6 weeks
Secondary outcomes:
measure: Between group differences in change in diastolic BP at 6 weeks follow-up and change in both systolic an diastolic BP at 12 weeks
timeFrame: Baseline to 6(and 12) weeks
measure: Between group differences in systolic and diastolic BP at 12 weeks follow-up
timeFrame: Baseline to 12 weeks
Other outcomes:
measure: Incidence of serious adverse events (eg dizziness) [Safety Outcomes]
timeFrame: Baseline to 6 months
measure: Number of eligible patient participants who utilized the HDP Implementation Bundle (Reach)
timeFrame: Baseline up to 57 months
measure: Between-group difference in change in systolic BP from baseline to 6-week follow-up (Effectiveness)
timeFrame: Baseline up to 6 weeks
measure: Number of clinical sites where the HDP Implementation Bundle was widely utilized (Adoption)
timeFrame: Baseline up to 57 months
measure: Number of clinical sites where the HDP Implementation Bundle was implemented as intended (Implementation)
timeFrame: Baseline up to 57 months
measure: Number of clinical sites and patients that continue use of the HDP Implementation Bundle post completion. (Maintenance)
timeFrame: End of study at month 57 to 1 year post-completion
measure: Incidence of adverse events of special interest [Safety & Exploratory Outcomes]
timeFrame: Baseline to 6 months
measure: Between-group differences in change in diastolic BP at 6 weeks. (Effectiveness)
timeFrame: Baseline up to 6 weeks
measure: Between-group differences in change in systolic BP at 12 weeks. (Effectiveness)
timeFrame: Baseline to 12 weeks
measure: Between-group differences in change in diastolic BP at 12 weeks. (Effectiveness)
timeFrame: Baseline to 12 weeks
measure: Between-group differences in change in proportion of BP control at 6 weeks. (Effectiveness)
timeFrame: Baseline up to 6 weeks
measure: Between-group differences in change in proportion of BP control at 12 weeks. (Effectiveness)
timeFrame: Baseline to 12 weeks
measure: Composite rate of fatal and nonfatal cardiovascular disease events. [Safety and Exploratory Outcomes]
timeFrame: Baseline up to 6 months
Locations:
city: Abuja
country: Nigeria
facility: National Hospital, Abuja
city: Abuja
country: Nigeria
facility: University of Abuja Teaching Hospital
city: Kano
country: Nigeria
facility: Aminu Kano Teaching Hospital
city: Kano
country: Nigeria
facility: Murtala Muhammad Specialist Hospital
Study officials:
affiliation: Washington University School of Medicine
name: Zainab Mahmoud, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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