An interventional study of Hypertension Disorders of Pregnancy (HDP) Implementation Bundle in Hypertensive Disorder of Pregnancy, sponsored by Washington University School of Medicine. Recruiting at 4 sites in Nigeria. Open to female participants. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Other
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?
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Other: Hypertension Disorders of Pregnancy (HDP) Implementation Bundle
The 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
Time frame: Baseline to 6 weeks
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.
Time frame: Baseline to 6(and 12) weeks
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
Time frame: Baseline to 12 weeks
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
Time frame: Baseline to 6 months
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.
Time frame: Baseline up to 57 months
Between-group difference in change in systolic BP from baseline to 6-week follow-up (Effectiveness)
Did the HDP Implementation Bundle impact effectiveness outcomes?
Time frame: Baseline up to 6 weeks
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.
Time frame: Baseline up to 57 months
Number of clinical sites where the HDP Implementation Bundle was implemented as intended (Implementation)
Clinical site records and surveys assessed to evaluate whether the HDP Implementation Bundle was implemented as intended per the study protocol.
Time frame: Baseline up to 57 months
Number of clinical sites and patients that continue use of the HDP Implementation Bundle post completion. (Maintenance)
Can the HDP Implementation Bundle be sustained? Continued use of the HDP Implementation Bundle or its components post-implementation.
Time frame: End of study at month 57 to 1 year post-completion
Incidence of adverse events of special interest [Safety & Exploratory Outcomes]
Exploratory outcomes include incidence of adverse events of special interest (e.g., dizziness, syncope, acute kidney injury) that will be collected via surveys and patient charts at 6- weeks,12-weeks and 6-months postpartum that could form the basis of new research questions or useful in developing hypotheses for exploring new research foci.
Time frame: Baseline to 6 months
Between-group differences in change in diastolic BP at 6 weeks. (Effectiveness)
Did the HDP Implementation Bundle impact effectiveness outcomes
Time frame: Baseline up to 6 weeks
Between-group differences in change in systolic BP at 12 weeks. (Effectiveness)
Did the HDP Bundle impact effectiveness outcomes?
Time frame: Baseline to 12 weeks
Between-group differences in change in diastolic BP at 12 weeks. (Effectiveness)
Did the HDP Implementation Bundle impact effectiveness outcomes?
Time frame: Baseline to 12 weeks
Between-group differences in change in proportion of BP control at 6 weeks. (Effectiveness)
Did the HDP Implementation Bundle impact effectiveness outcomes
Time frame: Baseline up to 6 weeks
Between-group differences in change in proportion of BP control at 12 weeks. (Effectiveness)
Did the HDP Implementation Bundle impact effectiveness outcomes?
Time frame: Baseline to 12 weeks
Composite rate of fatal and nonfatal cardiovascular disease events. [Safety and Exploratory Outcomes]
The composite rate of fatal and nonfatal cardiovascular disease events will be calculated as the total sum of both fatal and nonfatal events out of the total study population times a hundred at 6 weeks, 12 weeks and 6 months as follows: Composite CVD Event Rate= (Total Study Population/Total Fatal + Nonfatal Events) ×100
Time frame: Baseline up to 6 months
Plan to share: Yes — All data will be securely captured and stored within the University of Abuja REDCap system. The investigators will seek IRB approval from Washington University in St. Louis to access and analyze potentially identifiable information for the proposes of data analysis across the study aims. Data will be stored in secure, password protected servers with audit trails and accessibility only to trained study team members who have received IRB approval for access. The investigators will comply with the NIH policy for Data Management and Sharing (NOT-OD-21-013) and will share our protocol, data dictionary, statistical code and analysis plan with others, as soon as possible, and no later than time of an associated publication or end of the award period, whichever comes first.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: April 2029 - April 2034
Access criteria: Access to this data will be made available via BioLINCC in accordance with NHLBI guidelines and due process, as this will be a controlled access database. All individuals requesting the data must submit an application with a research plan and documentation of review by an IRB.
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