Home Assessment of Blood Pressure in PregnancY
ConditionHypertensive Disorder of Pregnancy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age19+
SponsorUniversity of British Columbia
About this trial
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
Eligibility criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- Home blood pressure telemonitoring program and clinician monitoring
Treatment groups
No treatment groups listed
Sponsors and collaborators
University of British Columbia
Lead sponsor
Women's Health Research Institute of British Columbia
Collaborator
Providence Healthcare
Collaborator
Fraser Health
Collaborator
Source ClinicalTrials.gov