University of Pittsburgh Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
NCT Number: NCT06069102
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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Notify Me18 year–55 year
Female
Interventional
Phase 4
Pittsburgh, Pennsylvania, 15213, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Other names: Tight control
Time frame: Baseline to approximately 6 months postpartum, a total of 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.
Time frame: 6 months postpartum
Number of participants with anti-hypertensive medication use
Time frame: 6 weeks postpartum
Anti-hypertensive medication use
Time frame: 6 months postpartum
Mean arterial pressure (systolic BP + 2*diastolic BP / 3)
Time frame: 6 weeks postpartum
Mean arterial pressure (systolic BP + 2*diastolic BP / 3)
Time frame: 6 months postpartum
Mean systolic blood pressure
Time frame: 6 months postpartum
Mean diastolic blood pressure
Time frame: 6 weeks postpartum
Mean diastolic blood pressure
Time frame: 6 weeks postpartum
Change in mean arterial pressure (systolic BP + 2*diastolic BP / 3) from baseline
Time frame: 6 weeks postpartum
Change in systolic BP from baseline
Time frame: 6 weeks postpartum
Change in diastolic BP from baseline
Time frame: Six months postpartum
Postpartum hospital readmissions
Time frame: Six months postpartum
Emergency room visits
Time frame: 6 weeks postpartum
Number of participants retained to 6 weeks postpartum
Time frame: 6 months postpartum
Retention of participants to 6 months postpartum
Alisse Hauspurg
Other
OPT-BP: Optimal Blood Pressure Treatment Thresholds Following a Hypertensive Disorder of Pregnancy: A Pilot Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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