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Hypertensive Disorder of PregnancyIMPACT-HDPNCT06859359

Improving Maternal Cardiovascular Outcomes Through the Implementation of a Hypertensive Disorders of Pregnancy Bundle in Nigeria

A study testing Hypertension Disorders of Pregnancy (HDP) Implementation Bundle in people with Hypertensive Disorder of Pregnancy, run by Washington University School of Medicine at 4 sites in Nigeria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Hypertensive Disorder of Pregnancy
What is being tested?
Hypertension Disorders of Pregnancy (HDP) Implementation Bundle
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
4 sitesNigeria
Study dates
8 Aug 2024to Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • unable to provide consent.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dike Ojji, MBBS, PhD contact

+234-806-009-4456

dike.ojji@uniabuja.edu.ng

Kamilu Karaye, MBBS, PhD contact

+2348037042171

kkaraye@yahoo.co.uk

Nigeria4 sites, 4 recruiting

  • National Hospital, Abuja

    Abuja

    Elizabeth Tomilola-Emmanuel, MBBS, +2348133910560, tomilolaemmanuel@yahoo.com

    Adaego Ameth Orji, MBBS, +23480637996563, princessego2019@gmail.com

    Recruiting

  • University of Abuja Teaching Hospital

    Abuja

    Dike Ojji, MBBS, PhD, 234-806-009-4456, dike.ojji@uniabuja.edu.ng

    Francis Okoye, MBBS, +2348105979116, chukwuebukafrancisokoye@yahoo.com

    Recruiting

  • Aminu Kano Teaching Hospital

    Kano

    Kamilu Karaye, MBBS, PhD, +2348037042171., kkaraye@yahoo.co.uk

    Kabeer Karaye, MBBS, +2349036670008, kabeerkaraye@gmail.com

    Recruiting

  • Murtala Muhammad Specialist Hospital

    Kano

    Hadiza Saidu, MBBS, +2348033238333, hsaidu2006@yahoo.com

    Noura Idrees, MBBS, +2348065868650, nouridrees1@gmail.com

    Recruiting

Other trials in Nigeria

About this study

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?

Read the 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.

Being tested
Hypertension Disorders of Pregnancy (HDP) Implementation Bundle
Keywords
Hypertension, Pregnancy, Preeclampsia, HDP
Medical subject headings
Toxemia, Hypertension, Pre-Eclampsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypertension Disorders of Pregnancy (HDP) Implementation BundleOther

    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.

Study groups in NCT06859359
Study groupRoleWhat they receive
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.
Receives: Other: Hypertension Disorders of Pregnancy (HDP) Implementation Bundle

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline to 6 weeks

Secondary outcomes (2)

  1. 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.

    Measured: Baseline to 6(and 12) weeks

  2. 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

    Measured: Baseline to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2025
  2. Study start8 Aug 2024
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Type 1 hybrid stepped-wedge cluster randomized trial to assess if the utilization of the HDP Implementation Bundle will improve postpartum BP among women with HDP in Nigeria. Randomization will be done at cluster level and sites will begin in control and cross over to intervention phase
Masking
None (open label)
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06859359
Sponsor's protocol ID
202311185
Other IDs
K23HL173684
Acronym
IMPACT-HDP
Status last verified
Mar 2026
First submitted
6 Nov 2024
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • 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.

    PubMed 31487273

  • 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.

    PubMed 31071074

  • 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.

    PubMed 36440578

  • Howell EA. Reducing Disparities in Severe Maternal Morbidity and Mortality. Clin Obstet Gynecol. 2018 Jun;61(2):387-399. doi: 10.1097/GRF.0000000000000349.

    PubMed 29346121

  • 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.

    PubMed 34736568

  • 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.

    PubMed 36302590

  • 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.

    PubMed 33563007

  • 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.

    PubMed 34905954

  • 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.

    PubMed 35518118

  • 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.

    PubMed 30361107

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Hypertension Disorders of Pregnancy (HDP) Implementation Bundle in people with Hypertensive Disorder of Pregnancy, run by Washington University School of Medicine at 4 sites in Nigeria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dike Ojji, MBBS, PhD (+234-806-009-4456, dike.ojji@uniabuja.edu.ng), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Between group difference in change in systolic BP from baseline to 6-week follow-up (time frame: Baseline to 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06859359, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

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