Home Assessment of Blood Pressure in PregnancY

NCT06491199 | Not Yet Recruiting

• 1 other identifier: H23-03815
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertensive Disorder of Pregnancy

Outcome Measures

Primary Outcomes (4)

• Feasibility: recruitment rate of HBPT program

  Average number of participants who are screened and eligible who consent to participate in this study per month of recruitment.

  From time of enrolment to 6 weeks post partum

• Feasibility: retention rate of HBPT program

  Rate of patients who are consented and enrolled in study and participate for the duration of the study period compared to those who are lost to follow-up or attrite during the study period.

  From time of enrolment to 6 weeks post-partum

• Safety: Proportion of participants with severe hypertension.

  Number of patients who experience severe hypertension (defined as office/obstetrical visits/home systolic blood pressure (SBP) ≥ 160 mm Hg and/or diastolic blood pressure (DBP) ≥ 110 mm Hg) as a proportion of total study population.

  From time of enrolment to 6 weeks post-partum

• Safety: Incidence density of study participants with severe hypertension

  Proportion of new cases of severe hypertension (defined as office/obstetrical visits/home systolic blood pressure (SBP) ≥ 160 mm Hg and/or diastolic blood pressure (DBP) ≥ 110 mm Hg) divided by the total person-time from enrolment to 6 weeks post-partum.

  From time of enrolment to 6 weeks post-partum.

Secondary Outcomes (3)

• End-user acceptability of comprehensive HBPT program based on EuroQol 5 Dimension 5 Level

  From time of enrolment to end of study period (6 weeks postpartum).

• End-user acceptability of comprehensive HBPT program based on Spielberger State-Trait Anxiety Inventory 6 (STAI-6) questionnaire.

  From time of enrolment to end of study period (6 weeks postpartum).

• End-user acceptability of comprehensive HBPT program based on Patient Satisfaction Questionnaire Short Form (PSQ-18).

  From time of enrolment to end of study period (6 weeks postpartum).

Other Outcomes (9)

• Exploratory outcome: Maternal and perinatal adverse conditions

  From time of enrolment to end of study period (6 weeks postpartum).

• Exploratory outcome: Efficacy as defined by proportion of blood pressure readings within guideline readings

  From time of enrolment to end of study period (6 weeks postpartum).

• Exploratory outcome: Efficacy as defined by mean blood pressures

  2nd trimester (up to 24 weeks of gestation), 3rd trimester (up to 36 weeks gestation), post-partum (up to 6 weeks post-partum)

Interventions

Home blood pressure telemonitoring program and clinician monitoring OTHER

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People who are pregnant between 20+0 weeks and 26+0 weeks diagnosed with a hypertensive disorder of pregnancy (HDP) such as chronic hypertension, gestational hypertension, or transient elevated blood pressure with HDP risk factors.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Women's Health Research Institute of British Columbia: collaborator
• Providence Healthcare: collaborator
• Fraser Health: collaborator

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V5Z1M9, Canada

Location

MeSH Terms

Conditions

Toxemia

Condition Hierarchy (Ancestors)

Infections

Central Study Contacts

Karen Tran, MD

CONTACT

(604) 875-5181; Karen.Tran4@vch.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, General Internal Medicine

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: July 9, 2024
• Study Start: July 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 9, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)