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Learning to Evaluate Blood Pressure at Home (LEANBH)

NCT ID: NCT04671602

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-19

Study Completion Date

2021-08-31

Brief Summary

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COVID-19 has highlighted important deficiencies in our health service where front line staff and pregnant women are being exposed to SARS-Cov-2 through assessments that could be conducted using Connected Health solutions, reducing risks of contracting or disseminating SARS-Cov-2. Currently, pregnant women are not attending GPs or hospitals for BP monitoring for fear of contracting SARS-Cov-2. Uncontrolled or unmonitored hypertension in pregnancy is associated with maternal and fetal morbidity and mortality. The aim of the study is to use home BP monitoring as an adjunct to standard care for women with borderline/suspected hypertension in pregnancy. To reduce the exposure risk for staff and pregnant women, we propose the immediate implementation of ambulatory automated self BP monitoring using the LEANBH platform- an existing integrated platform to monitor pregnant women.

Detailed Description

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The COVID-19 pandemic exposes our front-line staff to unnecessary risks in interacting with COVID-19 affected patients. Current care of pregnant women who have uncontrolled/unmonitored hypertension involves multiple visits to obstetric units for blood pressure checks. These visits put the women at risk of contracting or transmitting SARS-CoV-2 by bringing them into hospitals for checks which could otherwise be done remotely. Up to 20% of pregnant women will experience a hypertensive episode during pregnancy or the postpartum period. Uncontrolled or unmonitored hypertension in pregnancy may be associated with significant maternal and fetal morbidity and mortality including pre-eclampsia, stroke and stillbirth. The current management of suspected hypertension in pregnancy involves prolonged admission to hospital for BP monitoring or multiple visits to day assessment units or primary care physicians. All of these increase the risk of contracting or transmitting SARS-CoV-2. In addition, pregnant women with COVID-19 who are receiving inpatient care also require regular BP monitoring increasing the exposure risk for staff of contracting SARS-CoV-2. Pregnant women not attending GPs or hospitals for BP monitoring out of fear of contracting COVID-19 drastically increase their risk of suffering adverse effects from undiagnosed or uncontrolled hypertension. The ideal solution would be to facilitate inpatient or outpatient monitoring with reduced face to face contact between staff and infected patients. This would ensure a safer experience for all by reducing the risk of contracting SARS-CoV-2 while safely offering remote BP monitoring. LEANBH offers this safe alternative to direct hospital contact for pregnant women and staff by providing ambulatory automated self BP monitoring using the LEANBH integrated platform. This proposal will deliver immediate ambulatory BP self-monitoring performed remotely without need for direct physical contact, minimising risk of exposure to SARS-CoV-2 for staff and pregnant women.

Conditions

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Hypertension in Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Aged 18 years or over.
* Ability to give informed consent.
* Mobile application compatible smartphone.
* Increased requirement for blood pressure monitoring in this pregnancy as determined by their treating obstetric team.
* Between 12 weeks of pregnancy and up to six weeks postpartum

Exclusion Criteria

* Inability to give informed consent (language barrier)
* Confirmed Preeclampsia
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Science Foundation Ireland

OTHER

Sponsor Role collaborator

University College Cork

OTHER

Sponsor Role lead

Responsible Party

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Fergus McCarthy

Consultant Obstetrician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cork University Maternity Hospital

Cork, , Ireland

Site Status RECRUITING

Countries

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Ireland

Central Contacts

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Fergus McCarthy

Role: CONTACT

Phone: +353 830409737

Email: [email protected]

Dawn Fisher

Role: CONTACT

Email: [email protected]

Facility Contacts

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Fergus McCarthy

Role: primary

Dawn Fisher

Role: backup

Other Identifiers

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FMC01UCC2020

Identifier Type: -

Identifier Source: org_study_id