Improving Maternal Cardiovascular Outcomes Through the Implementation of a Hypertensive Disorders of Pregnancy Bundle in Nigeria
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,200
- Locations
- 8
- Primary Endpoint
- Between group difference in change in systolic BP from baseline to 6-week follow-up
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control Phase: For capturing baseline parameters.
In the control phase, baseline data including postpartum BP measurement, treatment at enrollment and BP at 6- and 12-weeks follow-up will be recorded. BP control rates, and clinical outcomes will also be recorded.
Intervention Phase: Participants will crossover to the intervention phase after 12 months.
After a period of 12 months when all sites are in the control phase, crossover into the intervention phase will begin. The multilevel intervention will be the HDP Implementation Bundle. Patient education will be provided at time of participants' enrollment. This will cover knowledge of normal BP parameters, complications of HDP, warning symptoms, and advice on appropriate measures to take. A free automated BP monitor (e.g., Omron Series 3) will be provided and patients will be trained on BP measurement and instructed to report daily BP recordings via text messaging (similar to our feasibility study). Additionally, there will be a standardized follow-up interval (determined by Aim 1 results) for all patients with HDP and provision of free antihypertensive medications, if needed.
Intervention: Hypertension Disorders of Pregnancy (HDP) Implementation Bundle (Other)
Outcomes
Primary Outcomes
Between group difference in change in systolic BP from baseline to 6-week follow-up
Time Frame: Baseline to 6 weeks
The change in systolic BP from baseline to 6-week follow-up between the intervention and control group
Secondary Outcomes
- Between group differences in change in diastolic BP at 6 weeks follow-up and change in both systolic an diastolic BP at 12 weeks(Baseline to 6(and 12) weeks)
- Between group differences in systolic and diastolic BP at 12 weeks follow-up(Baseline to 12 weeks)
Investigators
Zainab Mahmoud
Assistant Professor of Medicine
Washington University School of Medicine