Improving Maternal Cardiovascular Outcomes Through the Implementation of a Hypertensive Disorders of Pregnancy Bundle in Nigeria (IMPACT-HDP)

March 25, 2026 updated by: Zainab Mahmoud, Washington University School of Medicine

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Nigeria
      • Abuja, Nigeria
      • Abuja, Nigeria
        • Recruiting
        • National Hospital, Abuja
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Elizabeth Tomiloloa -Emmanuel, MBBS
      • Kano, Nigeria
        • Recruiting
        • Aminu Kano Teaching Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Kamilu Karaye, MBBS, PhD
      • Kano, Nigeria
        • Recruiting
        • Murtala Muhammad Specialist Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Hadiza Saidu, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Between group differences in change in diastolic BP at 6 weeks follow-up and change in both systolic an diastolic BP at 12 weeks
Time Frame: Baseline to 6(and 12) weeks
The change in diastolic BP from baseline to 6-week follow-up between the intervention and control groups.
Baseline to 6(and 12) weeks
Between group differences in systolic and diastolic BP at 12 weeks follow-up
Time Frame: Baseline to 12 weeks
The change mean systolic and diastolic BPs 12 weeks follow-up between the intervention and control group
Baseline to 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of serious adverse events (eg dizziness) [Safety Outcomes]
Time Frame: Baseline to 6 months
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
Baseline to 6 months
Number of eligible patient participants who utilized the HDP Implementation Bundle (Reach)
Time Frame: Baseline up to 57 months
Number, age, socio-demographics of patients who were enrolled in the HDP Implementation Bundle.
Baseline up to 57 months
Between-group difference in change in systolic BP from baseline to 6-week follow-up (Effectiveness)
Time Frame: Baseline up to 6 weeks
Did the HDP Implementation Bundle impact effectiveness outcomes?
Baseline up to 6 weeks
Number of clinical sites where the HDP Implementation Bundle was widely utilized (Adoption)
Time Frame: Baseline up to 57 months
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.
Baseline up to 57 months
Number of clinical sites where the HDP Implementation Bundle was implemented as intended (Implementation)
Time Frame: Baseline up to 57 months
Clinical site records and surveys assessed to evaluate whether the HDP Implementation Bundle was implemented as intended per the study protocol.
Baseline up to 57 months
Number of clinical sites and patients that continue use of the HDP Implementation Bundle post completion. (Maintenance)
Time Frame: End of study at month 57 to 1 year post-completion
Can the HDP Implementation Bundle be sustained? Continued use of the HDP Implementation Bundle or its components post-implementation.
End of study at month 57 to 1 year post-completion
Incidence of adverse events of special interest [Safety & Exploratory Outcomes]
Time Frame: Baseline to 6 months
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.
Baseline to 6 months
Between-group differences in change in diastolic BP at 6 weeks. (Effectiveness)
Time Frame: Baseline up to 6 weeks
Did the HDP Implementation Bundle impact effectiveness outcomes
Baseline up to 6 weeks
Between-group differences in change in systolic BP at 12 weeks. (Effectiveness)
Time Frame: Baseline to 12 weeks
Did the HDP Bundle impact effectiveness outcomes?
Baseline to 12 weeks
Between-group differences in change in diastolic BP at 12 weeks. (Effectiveness)
Time Frame: Baseline to 12 weeks
Did the HDP Implementation Bundle impact effectiveness outcomes?
Baseline to 12 weeks
Between-group differences in change in proportion of BP control at 6 weeks. (Effectiveness)
Time Frame: Baseline up to 6 weeks
Did the HDP Implementation Bundle impact effectiveness outcomes
Baseline up to 6 weeks
Between-group differences in change in proportion of BP control at 12 weeks. (Effectiveness)
Time Frame: Baseline to 12 weeks
Did the HDP Implementation Bundle impact effectiveness outcomes?
Baseline to 12 weeks
Composite rate of fatal and nonfatal cardiovascular disease events. [Safety and Exploratory Outcomes]
Time Frame: Baseline up to 6 months

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
Baseline up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Zainab Mahmoud, MD, MSc, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2024

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

November 6, 2024

First Submitted That Met QC Criteria

February 27, 2025

First Posted (Actual)

March 5, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202311185
  • K23HL173684 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

April 2029 - April 2034

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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