Improving Maternal Cardiovascular Outcomes Through the Implementation of a Hypertensive Disorders of Pregnancy Bundle in Nigeria
NCT ID: NCT06859359
Last Updated: 2025-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1200 participants
INTERVENTIONAL
2025-06-02
2029-06-30
Brief Summary
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Will a contextualized home BP monitoring program lead to better BP control among patients with HDP in Nigeria?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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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.
No interventions assigned to this group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
FEMALE
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Washington University School of Medicine
OTHER
Responsible Party
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Zainab Mahmoud
Assistant Professor of Medicine
Principal Investigators
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Zainab Mahmoud, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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National Hospital, Abuja
Abuja, , Nigeria
University of Abuja Teaching Hospital
Abuja, , Nigeria
Aminu Kano Teaching Hospital
Kano, , Nigeria
Murtala Muhammad Specialist Hospital
Kano, , Nigeria
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Petersen 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.
Petersen 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.
Mahmoud 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.
Howell EA. Reducing Disparities in Severe Maternal Morbidity and Mortality. Clin Obstet Gynecol. 2018 Jun;61(2):387-399. doi: 10.1097/GRF.0000000000000349.
Lindley 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.
Ogunniyi 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.
WHO Recommendations for Prevention and Treatment of Pre-Eclampsia and Eclampsia - NCBI Bookshelf. https://www.ncbi.nlm.nih.gov/books/NBK140561/. Accessed 7 Feb 2023
Bond 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.
United Nations Sustainable Development Goals. https://www.un.org/sustainabledevelopment/health/. Accessed 8 May 2023
Charting 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
Garovic 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.
Tukur 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.
Alliance 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.
Trends 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.
Other Identifiers
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202311185
Identifier Type: -
Identifier Source: org_study_id
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