Optimal Blood Pressure Treatment Thresholds Postpartum

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2025-12-01

Brief Summary

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The objective of this research project is to conduct a single-site pilot trial within our institution's clinical remote blood pressures (BP) management program to assess the feasibility and effect of tight blood pressure control versus usual care in the immediate postpartum period after a hypertensive disorder of pregnancy (HDP).

The investigators' central hypothesis is that tight blood pressure control will be feasible and acceptable to postpartum individuals and will result in lower BP at six months postpartum and a reduction in postpartum hospital readmissions. Subjects will undergo 3 study visits (1 in-person and 2 remote) involving BP measurements, blood draws, and/or questionnaires. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.

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Detailed Description

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The investigators will determine the feasibility of conducting a randomized controlled trial of tight blood pressure control (\<135/85 mmHg on home BP monitoring) vs. standard of care (\<150/100 mmHg on home BP monitoring) in postpartum individuals following a HDP with assessment of individuals who are eligible, enrolled, and remain in the study until six weeks postpartum. Individuals who are retained in the study for 6 months postpartum. Lastly, investigators will analyze effect outcomes to inform the sample size for a subsequent large-scale randomized trial. This will be done through analysis of mean arterial pressure (MAP), systolic blood pressure, and diastolic blood pressure of participants at 6 weeks and at 6 months postpartum. The study will be conducted on the postpartum unit of Magee-Womens Hospital. Participants will be enrolled at the time of postpartum hospitalization with study visit #1 occurring in the hospital. At this study visit, participants will be administered questionnaires, will provide a blood sample, and BP will be measured. Study visit #2 will be a remote study visit conducted via telemedicine or a telephone call at 6 weeks postpartum. At this visit, participants will provide questionnaires and blood pressure data. Study visit #3 will be a remote study visit conducted via telemedicine or a telephone call at 6 months postpartum. At this visit, participants will again provide questionnaires and blood pressure data.

Conditions

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Hypertensive Disorder of Pregnancy Pre-Eclampsia Hypertension Eclampsia Gestational Hypertension Cardiovascular Diseases Toxemia Pregnancy Complications Vascular Diseases Hypertension, Pregnancy Induced Hypertension;Pre-Eclamptic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The investigators will conduct a prospective single site, single-blinded, parallel randomized control trial in which individuals diagnosed with HDP will be randomized to usual care or tight blood pressure control for therapeutic intent. Subjects will undergo 3 study visits (1 in-person and 2 remote) involving BP measurements, blood draws, and/or questionnaires.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Once randomization is complete, there will be no blinding of participants, care providers or investigators. Outcomes assessors will be masked to intervention arm.

Study Groups

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Usual Care Group

Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type DRUG

The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.

Intervention (Tight Blood Pressure Control) Group

BP medication will be started if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg.

Group Type EXPERIMENTAL

Tight blood pressure control

Intervention Type DRUG

The intervention group will be initiated on blood pressure medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's hospital BP consistently exceeds 140/90 mmHg or home BP consistently exceeds 135/85 mmHg.

Interventions

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Tight blood pressure control

The intervention group will be initiated on blood pressure medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's hospital BP consistently exceeds 140/90 mmHg or home BP consistently exceeds 135/85 mmHg.

Intervention Type DRUG

Usual care

The usual care group will be given anti-hypertensive medications (i.e. beta blocker, calcium channel blocker, etc) if a subject's BP consistently exceeds 150/100 mmHg consistently.

Intervention Type DRUG

Other Intervention Names

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Tight control

Eligibility Criteria

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Inclusion Criteria

* Postpartum individuals ≥18 years old
* Preeclampsia or gestational hypertension diagnosis (complying ACOG criteria)
* Enrolled in remote BP management program.