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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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?

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Nigeria
National Hospital, Abuja
RECRUITING
Abuja
University of Abuja Teaching Hospital
RECRUITING
Abuja
Aminu Kano Teaching Hospital
RECRUITING
Kano
Murtala Muhammad Specialist Hospital
RECRUITING
Kano
Contact Information
Primary
Dike Ojji, MBBS, PhD
dike.ojji@uniabuja.edu.ng
+234-806-009-4456
Backup
Kamilu Karaye, MBBS, PhD
kkaraye@yahoo.co.uk
+2348037042171
Time Frame
Start Date: 2025-06-02
Estimated Completion Date: 2029-06
Participants
Target number of participants: 1200
Treatments
No_intervention: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov