Optimal Blood Pressure Treatment Thresholds Postpartum

Phase 4

Active, not recruiting

• Conditions: Hypertensive Disorder of Pregnancy; Pre-Eclampsia; Hypertension; Eclampsia; Gestational Hypertension; Cardiovascular Diseases; Toxemia; Pregnancy Complications; Vascular Diseases; Hypertension, Pregnancy Induced
• Interventions: Drug: Usual care; Drug: Tight blood pressure control

• Registration Number: NCT06069102
• Lead Sponsor: Alisse Hauspurg

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-09-28
• Study First Submitted QC: 2023-09-28
• Study First Posted: 2023-10-05
• Study Start: 2023-11-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-07
• Primary Completion: 2025-05-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care Group	Usual care	Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.
Intervention (Tight Blood Pressure Control) Group	Tight blood pressure control	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.

Primary Outcome Measures

Name	Time	Method
Percent of participants eligible, enrolled and retained (feasibility)	Baseline to approximately 6 months postpartum	To determine if a randomized controlled trial of tight blood pressure control (\<135/85 mmHg on home blood pressure monitoring) vs. standard of care (\<150/100 mmHg on home blood pressure monitoring) in postpartum individuals following a hypertensive disorder of pregnancy (HDP) is feasible.

Secondary Outcome Measures

Name	Time	Method
Change in MAP	Enrollment to 6 weeks postpartum	Change in mean arterial pressure (systolic BP + 2\*diastolic BP / 3)
Change in systolic BP	Enrollment to 6 weeks postpartum	Change in systolic BP
Mean arterial pressure (efficacy)	6 months postpartum	Mean arterial pressure (systolic BP + 2\*diastolic BP / 3)
Anti-hypertensive medication use (efficacy)	6 months postpartum	Anti-hypertensive medication use
Diastolic blood pressure	6 weeks postpartum	Mean diastolic blood pressure
Anti-hypertensive medication use	6 weeks postpartum	Anti-hypertensive medication use
Change in diastolic BP	Enrollment to 6 weeks postpartum	Change in diastolic BP
Mean arterial pressure	6 weeks postpartum	Mean arterial pressure (systolic BP + 2\*diastolic BP / 3)
Systolic blood pressure	6 months postpartum	Mean systolic blood pressure
Proportion of participants with readmissions	Enrollment through six months postpartum	Postpartum hospital readmissions
Proportion of participants with ER visits	Enrollment through six months postpartum	Emergency room visits

Trial Locations

Locations (1)

University of Pittsburgh Magee-Womens Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States