Learning to Evaluate Blood Pressure at Home (LEANBH)

NCT04671602 | Unknown

• 1 other identifier: FMC01UCC2020
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension in Pregnancy

Outcome Measures

Primary Outcomes (1)

• Participant Satisfaction

  The primary outcome measure will be participant satisfaction with home blood pressure monitoring. Once a participant completes the LEANBH Study, an online system usability scale will be sent to all participants. This questionnaire contains 35 questions which will accurately capture user experience and satisfaction while participating in the study.

  12-42 weeks gestation

Secondary Outcomes (2)

• Clinical Escalation

  12-42 weeks gestation

• Adverse Events

  12 weeks gestation - 6 weeks postpartum

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All legally adult women with an ongoing, confirmed intrauterine pregnancy.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with an ongoing, confirmed intrauterine pregnancy who have borderline high blood pressure or are at risk of developing high blood pressure in this pregnancy and are due to give birth in Cork University Maternity Hospital.

You may qualify if:

• 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

You may not qualify if:

• Inability to give informed consent (language barrier)
• Confirmed Preeclampsia

Sponsors & Collaborators

• University College Cork: lead
• Science Foundation Ireland: collaborator

Study Sites (1)

Cork University Maternity Hospital

Cork, Ireland

RECRUITING

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Fergus McCarthy

CONTACT

+353 830409737; fergus.mccarthy@ucc.ie

Dawn Fisher

CONTACT

dawn.fisher@ucc.ie

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Obstetrician

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 17, 2020
• Study Start: August 19, 2020
• Primary Completion: February 28, 2021
• Study Completion: August 31, 2021
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)