Home Assessment of Blood Pressure in PregnancY

NCT ID: NCT06491199

Last Updated: 2024-07-09

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

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-31

Study Completion Date

2026-01-31

Brief Summary

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The goal of this observational study is to evaluate the feasibility and safety of a comprehensive home blood pressure telemonitoring (HBPT) program for pregnant people with hypertensive disorders of pregnancy (HDP).

Participants will receive training on the use of a home BP telemonitor with tele-transmission function for the remainder of their pregnancy and 6 weeks postpartum. Participating obstetric internal medicine (OBIM) clinicians will monitor the transmitted values and adjust anti-hypertensive medications based on the home BP readings.

Our primary goal is to describe the feasibility and safety of a comprehensive HBPT pilot program in British Columbia, Canada (BC).

Secondary research questions will address:

1. What is the end-user acceptability of a comprehensive HBPT pilot program in BC?
2. What are the effects of a comprehensive HBPT pilot program on factors such as:

1\. Maternal and neonatal outcomes 2. Home blood pressure (BP) metrics 3. Process measures 4. Anti-hypertensive medications 5. Fidelity to interventions 6. Health Care utilization

Detailed Description

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Conditions

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Hypertensive Disorder of Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Home blood pressure telemonitoring program and clinician monitoring

Home Blood Pressure Telemonitoring (HBPT) includes used of an app to collect and transmit blood pressure readings.

Clinician monitoring includes OBIM physicians reviewing transmitted BP data and contacting patients to adjust antihypertensive medication regimens.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients aged ≥ 19 years
* Pregnancy
* Gestational age 20+0 to 36+0 weeks gestational age
* Diagnosed with gestational hypertension (defined as SBP ≥140 mm Hg and/or DBP ≥ 90 mm Hg) after 20 weeks gestation OR Chronic hypertension (defined as SBP ≥140 mm Hg and/or DBP ≥ 90 mm Hg), present at booking or before 20 weeks gestation, or receiving treatment (including lifestyle measures) prior to pregnancy and/or at time of referral OR Transient elevated office BP reading (defined as one time reading of SBP ≥140 mm Hg and/or DBP ≥ 90 mm Hg with risk factors for HDP as per Canadian guidelines).
* Participant is willing and able to give informed consent for participation in the study
* Able and willing to comply with study requirements
* Has smart phone

Exclusion Criteria

* Anticipated inpatient admission
* Remaining pregnancy less than 2 weeks duration
* Imminent delivery (within the next 48 hours)
* Non-English speaking or no family members who can help translate
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Women's Health Research Institute of British Columbia

OTHER

Sponsor Role collaborator

Providence Healthcare

OTHER

Sponsor Role collaborator

Fraser Health

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Karen Tran

Clinical Assistant Professor, General Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of British Columbia

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Central Contacts

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Karen Tran, MD

Role: CONTACT

(604) 875-5181

Other Identifiers

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H23-03815

Identifier Type: -

Identifier Source: org_study_id

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