NCT Number: NCT06859359
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?
Interested in participating?
Request InfoFemale
Interventional
Not applicable
National Hospital, Abuja, Abuja, Nigeria
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline to 6 weeks
The change in systolic BP from baseline to 6-week follow-up between the intervention and control group
Time frame: Baseline to 6(and 12) weeks
The change in diastolic BP from baseline to 6-week follow-up between the intervention and control groups.
Time frame: Baseline to 12 weeks
The change mean systolic and diastolic BPs 12 weeks follow-up between the intervention and control group
Time frame: Baseline to 6 months
Safety outcomes include incidence of serious adverse events (eg dizziness) collected via surveys and patient charts at 6- weeks,12-weeks and 6-months postpartum
Time frame: Baseline up to 57 months
Number, age, socio-demographics of patients who were enrolled in the HDP Implementation Bundle.
Time frame: Baseline up to 6 weeks
Did the HDP Implementation Bundle impact effectiveness outcomes?
Time frame: Baseline up to 57 months
Records and surveys assessed to establish whether the HDP Implementation Bundle was widely utilized at clinical sites. Patient enrolment in HDP Bundle, where at least 1 home BP measurement is reported among total participants.
Time frame: Baseline up to 57 months
Clinical site records and surveys assessed to evaluate whether the HDP Implementation Bundle was implemented as intended per the study protocol.
Time frame: End of study at month 57 to 1 year post-completion
Can the HDP Implementation Bundle be sustained? Continued use of the HDP Implementation Bundle or its components post-implementation.
Time frame: Baseline to 6 months
Exploratory outcomes include incidence of adverse events of special interest (e.g., dizziness, syncope, acute kidney injury) that will be collected via surveys and patient charts at 6- weeks,12-weeks and 6-months postpartum that could form the basis of new research questions or useful in developing hypotheses for exploring new research foci.
Time frame: Baseline up to 6 weeks
Did the HDP Implementation Bundle impact effectiveness outcomes
Time frame: Baseline to 12 weeks
Did the HDP Bundle impact effectiveness outcomes?
Time frame: Baseline to 12 weeks
Did the HDP Implementation Bundle impact effectiveness outcomes?
Time frame: Baseline up to 6 weeks
Did the HDP Implementation Bundle impact effectiveness outcomes
Time frame: Baseline to 12 weeks
Did the HDP Implementation Bundle impact effectiveness outcomes?
Time frame: Baseline up to 6 months
The composite rate of fatal and nonfatal cardiovascular disease events will be calculated as the total sum of both fatal and nonfatal events out of the total study population times a hundred at 6 weeks, 12 weeks and 6 months as follows:
Composite CVD Event Rate= (Total Study Population/Total Fatal + Nonfatal Events) ×100
Contact information is provided by the study sponsor or research team.
Dike Ojji, MBBS, PhD
CONTACT
Kamilu Karaye, MBBS, PhD
CONTACT
Washington University School of Medicine
Other
Acronym: IMPACT-HDP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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