Improving Maternal Cardiovascular Outcomes Through the Implementation of a Hypertensive Disorders of Pregnancy Bundle in Nigeria
IMPACT-HDP
2 other identifiers
interventional
1,200
1 country
4
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2024
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 8, 2024
CompletedFirst Submitted
Initial submission to the registry
November 6, 2024
CompletedFirst Posted
Study publicly available on registry
March 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
March 30, 2026
March 1, 2026
3.8 years
November 6, 2024
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Baseline to 6 weeks
Secondary Outcomes (2)
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
Other Outcomes (13)
Incidence of serious adverse events (eg dizziness) [Safety Outcomes]
Baseline to 6 months
Number of eligible patient participants who utilized the HDP Implementation Bundle (Reach)
Baseline up to 57 months
Between-group difference in change in systolic BP from baseline to 6-week follow-up (Effectiveness)
Baseline up to 6 weeks
- +10 more other outcomes
Study Arms (2)
Control Phase: For capturing baseline parameters.
NO INTERVENTIONIn 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.
EXPERIMENTALAfter 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- unable to provide consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
National Hospital, Abuja
Abuja, Nigeria
University of Abuja Teaching Hospital
Abuja, Nigeria
Aminu Kano Teaching Hospital
Kano, Nigeria
Murtala Muhammad Specialist Hospital
Kano, Nigeria
Related Publications (15)
Federal Ministry of Health. Nigeria hypertension treatment protocol for the primary care level. Available at: https://linkscommunity.org/assets/PDFs/nigeria-hypertension-protocol-04.pdf.
BACKGROUNDPetersen EE, Davis NL, Goodman D, Cox S, Syverson C, Seed K, Shapiro-Mendoza C, Callaghan WM, Barfield W. Racial/Ethnic Disparities in Pregnancy-Related Deaths - United States, 2007-2016. MMWR Morb Mortal Wkly Rep. 2019 Sep 6;68(35):762-765. doi: 10.15585/mmwr.mm6835a3.
PMID: 31487273BACKGROUNDPetersen EE, Davis NL, Goodman D, Cox S, Mayes N, Johnston E, Syverson C, Seed K, Shapiro-Mendoza CK, Callaghan WM, Barfield W. Vital Signs: Pregnancy-Related Deaths, United States, 2011-2015, and Strategies for Prevention, 13 States, 2013-2017. MMWR Morb Mortal Wkly Rep. 2019 May 10;68(18):423-429. doi: 10.15585/mmwr.mm6818e1.
PMID: 31071074BACKGROUNDMahmoud Z, Joynt Maddox KE, Deych E, Lindley KJ. Racial Disparities in Specific Maternal Cardiovascular Outcomes. Circ Cardiovasc Qual Outcomes. 2022 Dec;15(12):e009529. doi: 10.1161/CIRCOUTCOMES.122.009529. Epub 2022 Nov 28. No abstract available.
PMID: 36440578BACKGROUNDHowell EA. Reducing Disparities in Severe Maternal Morbidity and Mortality. Clin Obstet Gynecol. 2018 Jun;61(2):387-399. doi: 10.1097/GRF.0000000000000349.
PMID: 29346121BACKGROUNDLindley KJ, Aggarwal NR, Briller JE, Davis MB, Douglass P, Epps KC, Fleg JL, Hayes S, Itchhaporia D, Mahmoud Z, Moraes De Oliveira GM, Ogunniyi MO, Quesada O, Russo AM, Sharma J, Wood MJ; American College of Cardiology Cardiovascular Disease in Women Committee and the American College of Cardiology Health Equity Taskforce. Socioeconomic Determinants of Health and Cardiovascular Outcomes in Women: JACC Review Topic of the Week. J Am Coll Cardiol. 2021 Nov 9;78(19):1919-1929. doi: 10.1016/j.jacc.2021.09.011.
PMID: 34736568BACKGROUNDOgunniyi MO, Mahmoud Z, Commodore-Mensah Y, Fleg JL, Fatade YA, Quesada O, Aggarwal NR, Mattina DJ, Moraes De Oliveira GM, Lindley KJ, Ovbiagele B, Roswell RO, Douglass PL, Itchhaporia D, Hayes SN; American College of Cardiology Cardiovascular Disease in Women Committee and the American College of Cardiology Health Equity Taskforce. Eliminating Disparities in Cardiovascular Disease for Black Women: JACC Review Topic of the Week. J Am Coll Cardiol. 2022 Nov 1;80(18):1762-1771. doi: 10.1016/j.jacc.2022.08.769.
PMID: 36302590BACKGROUNDWHO Recommendations for Prevention and Treatment of Pre-Eclampsia and Eclampsia - NCBI Bookshelf. https://www.ncbi.nlm.nih.gov/books/NBK140561/. Accessed 7 Feb 2023
BACKGROUNDBond RM, Gaither K, Nasser SA, Albert MA, Ferdinand KC, Njoroge JN, Parapid B, Hayes SN, Pegus C, Sogade B, Grodzinsky A, Watson KE, McCullough CA, Ofili E; Association of Black Cardiologists. Working Agenda for Black Mothers: A Position Paper From the Association of Black Cardiologists on Solutions to Improving Black Maternal Health. Circ Cardiovasc Qual Outcomes. 2021 Feb;14(2):e007643. doi: 10.1161/CIRCOUTCOMES.120.007643. Epub 2021 Feb 10.
PMID: 33563007BACKGROUNDUnited Nations Sustainable Development Goals. https://www.un.org/sustainabledevelopment/health/. Accessed 8 May 2023
BACKGROUNDCharting the Future Together: The NHLBI Strategic Vision. https://www.nhlbi.nih.gov/sites/default/files/2017-11/NHLBI-Strategic-Vision-2016_FF.pdf. Accessed 15 May 2023
BACKGROUNDGarovic VD, Dechend R, Easterling T, Karumanchi SA, McMurtry Baird S, Magee LA, Rana S, Vermunt JV, August P; American Heart Association Council on Hypertension; Council on the Kidney in Cardiovascular Disease, Kidney in Heart Disease Science Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Lifestyle and Cardiometabolic Health; Council on Peripheral Vascular Disease; and Stroke Council. Hypertension in Pregnancy: Diagnosis, Blood Pressure Goals, and Pharmacotherapy: A Scientific Statement From the American Heart Association. Hypertension. 2022 Feb;79(2):e21-e41. doi: 10.1161/HYP.0000000000000208. Epub 2021 Dec 15.
PMID: 34905954BACKGROUNDTukur J, Lavin T, Adanikin A, Abdussalam M, Bankole K, Ekott MI, Godwin A, Ibrahim HA, Ikechukwu O, Kadas SA, Nwokeji-Onwe L, Nzeribe E, Ogunkunle TO, Oyeneyin L, Tunau KA, Bello M, Aminu I, Ezekwe B, Aboyeji P, Adesina OA, Chama C, Etuk S, Galadanci H, Ikechebelu J, Oladapo OT; Maternal and Perinatal Database for Quality, Equity and Dignity Network. Quality and outcomes of maternal and perinatal care for 76,563 pregnancies reported in a nationwide network of Nigerian referral-level hospitals. EClinicalMedicine. 2022 Apr 28;47:101411. doi: 10.1016/j.eclinm.2022.101411. eCollection 2022 May.
PMID: 35518118BACKGROUNDAlliance for Maternal and Newborn Health Improvement (AMANHI) mortality study group. Population-based rates, timing, and causes of maternal deaths, stillbirths, and neonatal deaths in south Asia and sub-Saharan Africa: a multi-country prospective cohort study. Lancet Glob Health. 2018 Dec;6(12):e1297-e1308. doi: 10.1016/S2214-109X(18)30385-1. Epub 2018 Oct 22.
PMID: 30361107BACKGROUNDTrends in maternal mortality 2000 to 2020: estimates by WHO, UNICEF, UNFPA, World Bank Group and UNDESA/Population Division. https://www.who.int/publications/i/item/9789240068759.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zainab Mahmoud, MD, MSc
Washington University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
November 6, 2024
First Posted
March 5, 2025
Study Start
August 8, 2024
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2029
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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.