Hypertension in PregnancyLEANBHNCT04671602
Learning to Evaluate Blood Pressure at Home (LEANBH)
An observational study of Hypertension in Pregnancy, run by University College Cork at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertension in Pregnancy
- How many people
- 500 participants
- Where
- 1 siteIreland
- Study dates
- 19 Aug 2020to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Inability to give informed consent (language barrier)
- Confirmed Preeclampsia
Trial locations and contacts
1 site in 1 country.
Dawn Fisher contact
Ireland1 site, 1 recruiting
- Recruiting
Cork University Maternity Hospital
Cork
Fergus McCarthy, fergus.mccarthy@ucc.ie
Dawn Fisher, dawn.fisher@ucc.ie
About this study
Official title: Implementing LEANBH Ambulatory Integrated Blood Pressure Monitoring in Maternity Services
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.
Read the detailed description
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
- Hypertension in Pregnancy
- Medical subject headings
- Hypertension, Pregnancy-Induced
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-42 weeks gestation
Secondary outcomes (2)
Clinical Escalation
The secondary outcome measure is the clinical escalation offered to participants as part of the LEANBH study. Home BP readings will be reviewed daily and clinical escalation offered when appropriate throughout the study.
Measured: 12-42 weeks gestation
Adverse Events
Preeclampsia, Preterm Delivery, IUGR, Postnatal Hospital Stay and Admission to NNU will all be considered as adverse events for the purpose of this study.
Measured: 12 weeks gestation - 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start19 Aug 2020
- Primary completion28 Feb 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- Science Foundation Ireland
- Responsible party
- Principal investigator, Fergus McCarthy, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671602
- Sponsor's protocol ID
- FMC01UCC2020
- Acronym
- LEANBH
- Status last verified
- Dec 2020
- First submitted
- 11 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing LEANBH Ambulatory Integrated Blood Pressure Monitoring in Maternity Services
- ClinicalTrials.gov ID
- NCT04671602
- Acronym / sponsor ID
- LEANBH / FMC01UCC2020
- Conditions
- Hypertension in Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- Science Foundation Ireland
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to give informed consent (language barrier)
- Confirmed Preeclampsia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participant Satisfaction
Time frame: 12-42 weeks gestation
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.
2 secondary outcomes
Clinical Escalation
Time frame: 12-42 weeks gestation
Adverse Events
Time frame: 12 weeks gestation - 6 weeks postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Fisher contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension in Pregnancy, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fergus McCarthy (+353 830409737, fergus.mccarthy@ucc.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Satisfaction (time frame: 12-42 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.