NCT06069102

Optimal Blood Pressure Treatment Thresholds Postpartum

OPT-BP: Optimal Blood Pressure Treatment Thresholds Following a Hypertensive Disorder of Pregnancy: A Pilot Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Alisse Hauspurg · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.
DRUG	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.

Timeline

• Start date: 2023-11-15
• Primary completion: 2025-05-01
• Completion: 2025-12-01
• First posted: 2023-10-05
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study