Optimal Blood Pressure Treatment Thresholds Postpartum

Alisse Hauspurg

Status and phase: Active, not recruiting; Phase 4

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

Treatments: Drug: Tight blood pressure control; Drug: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT06069102

STUDY23060147

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Pre-pregnancy hypertension
• Pre-pregnancy diabetes
• Maternal cardiac disease
• Chronic kidney disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Usual Care Group

Active Comparator group

Description:

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

Treatment:

Drug: Usual care

Intervention (Tight Blood Pressure Control) Group

Experimental group

Description:

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.

Treatment:

Drug: Tight blood pressure control