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

Not Applicable

Recruiting

• Conditions: Hypertensive Disorder of Pregnancy

• Registration Number: NCT06859359
• Lead Sponsor: Washington University School of Medicine

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?

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 Timeline

• Study Start: 2024-08-08
• Study First Submitted: 2024-11-06
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-27
• Last Update Submitted: 2025-02-27
• Study First Posted: 2025-03-05
• Last Update Posted: 2025-03-05
• Primary Completion: 2028-06
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Between group difference in change in systolic BP from baseline to 6-week follow-up	Baseline to 6 weeks	The change in systolic BP from baseline to 6-week follow-up between the intervention and control group

Secondary Outcome Measures

Name	Time	Method
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	The change in diastolic BP from baseline to 6-week follow-up between the intervention and control groups.
Between group differences in systolic and diastolic BP at 12 weeks follow-up	Baseline to 12 weeks	The change mean systolic and diastolic BPs 12 weeks follow-up between the intervention and control group

Trial Locations

Locations (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