Hypertension Clinical Trial
Official title:
OPT-BP: Optimal Blood Pressure Treatment Thresholds Following a Hypertensive Disorder of Pregnancy: A Pilot Trial
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Magee-Womens Hospital | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Alisse Hauspurg |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent of participants eligible, enrolled and retained (feasibility) | 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. | Baseline to approximately 6 months postpartum | |
Secondary | Anti-hypertensive medication use (efficacy) | Anti-hypertensive medication use | 6 months postpartum | |
Secondary | Anti-hypertensive medication use | Anti-hypertensive medication use | 6 weeks postpartum | |
Secondary | Mean arterial pressure (efficacy) | Mean arterial pressure (systolic BP + 2*diastolic BP / 3) | 6 months postpartum | |
Secondary | Mean arterial pressure | Mean arterial pressure (systolic BP + 2*diastolic BP / 3) | 6 weeks postpartum | |
Secondary | Systolic blood pressure | Mean systolic blood pressure | 6 months postpartum | |
Secondary | Diastolic blood pressure | Mean diastolic blood pressure | 6 months postpartum | |
Secondary | Diastolic blood pressure | Mean diastolic blood pressure | 6 weeks postpartum | |
Secondary | Change in MAP | Change in mean arterial pressure (systolic BP + 2*diastolic BP / 3) | Enrollment to 6 weeks postpartum | |
Secondary | Change in systolic BP | Change in systolic BP | Enrollment to 6 weeks postpartum | |
Secondary | Change in diastolic BP | Change in diastolic BP | Enrollment to 6 weeks postpartum | |
Secondary | Proportion of participants with readmissions | Postpartum hospital readmissions | Enrollment through six months postpartum | |
Secondary | Proportion of participants with ER visits | Emergency room visits | Enrollment through six months postpartum |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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