Actively Recruiting

Phase Not Applicable
FEMALE
ID06859359

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

Led by Washington University School of Medicine · Updated on 2026-03-30

1200

Participants Needed

4

Research Sites

52 weeks

Total Duration

On this page

Sponsors

W

Washington University School of Medicine

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the best ways to develop and use a management package for women with Hypertensive Disorders of Pregnancy (HDP) in Nigeria. The study aims to find out if a home blood pressure (BP) monitoring program, tailored for local needs, can improve BP control and cardiovascular health for pregnant women with HDP. This project is conducted at four health institutions in Abuja and Kano, Nigeria. The study has two phases. During the control phase, baseline data like postpartum BP measurements and treatments are recorded. After 12 months, participants switch to the intervention phase where they receive the HDP Implementation Bundle. This bundle includes patient education about BP and HDP risks, training on home BP monitoring with a free automated BP monitor, a standardized follow-up plan, and free antihypertensive medications if needed. Participants will have their BP measured and recorded at enrollment, and again at 6 and 12 weeks postpartum. The study measures differences in systolic and diastolic BP between the control and intervention phases. The researchers will also evaluate how well the program is accepted and followed. This study runs until June 2029, with ongoing monitoring of participants' cardiovascular health and BP control.

CONDITIONS

Brief Title

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

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Postpartum adults over 18 years old
  • Postpartum emancipated minors as per Nigerian guidelines
  • Diagnosed with hypertensive disorders of pregnancy before delivery
  • Delivered at one of the participating health institutions
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Unable to provide consent

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Control Phase

Duration - 12 months

Participants have baseline data collected including postpartum blood pressure measurements and treatment details. Follow-up visits occur to record blood pressure at 6 and 12 weeks postpartum.

Visits at enrollment, 6 weeks, and 12 weeks postpartum

Intervention Phase

Duration - Up to 12 weeks postpartum

Participants crossover to receive the Hypertensive Disorders of Pregnancy Implementation Bundle, including patient education, home blood pressure monitoring with a provided BP monitor, a standardized follow-up protocol, and provision of free antihypertensive medications if needed.

Daily remote blood pressure reporting and follow-up visits according to the standardized protocol

Trial Site Locations

Total: 4 locations

1

National Hospital, Abuja

Abuja, Nigeria

Actively Recruiting

2

University of Abuja Teaching Hospital

Abuja, Nigeria

Actively Recruiting

3

Aminu Kano Teaching Hospital

Kano, Nigeria

Actively Recruiting

4

Murtala Muhammad Specialist Hospital

Kano, Nigeria

Actively Recruiting

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Research Team

D

Dike Ojji, MBBS, PhD

K

Kamilu Karaye, MBBS, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

2

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Published Research Related To This Trial

Vital Signs: Pregnancy-Related Deaths, United States, 2011-2015, and Strategies for Prevention, 13 States, 2013-2017.

Emily E Petersen, Nicole L Davis, David Goodman...

https://pubmed.ncbi.nlm.nih.gov/31071074

Working Agenda for Black Mothers: A Position Paper From the Association of Black Cardiologists on Solutions to Improving Black Maternal Health.

Rachel M Bond, Kecia Gaither, Samar A Nasser...

https://pubmed.ncbi.nlm.nih.gov/33563007

Hypertension in Pregnancy: Diagnosis, Blood Pressure Goals, and Pharmacotherapy: A Scientific Statement From the American Heart Association.

Vesna D Garovic, Ralf Dechend, Thomas Easterling...

https://pubmed.ncbi.nlm.nih.gov/34905954

Quality and outcomes of maternal and perinatal care for 76,563 pregnancies reported in a nationwide network of Nigerian referral-level hospitals.

Jamilu Tukur, Tina Lavin, Abiodun Adanikin...

https://pubmed.ncbi.nlm.nih.gov/35518118

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.

Alliance for Maternal and Newborn Health Improvement (AMANHI) mortality study group

https://pubmed.ncbi.nlm.nih.gov/30361107