Cardiovascular Diseases, Eclampsia, Gestational Hypertension, Hypertension, Hypertension;Pre-Eclamptic, Hypertension, Pregnancy Induced, Hypertensive Disorder of Pregnancy, Pre-Eclampsia, Pregnancy Complications, Toxemia, Vascular Diseases
Conditions
Keywords
Hypertension
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.
Interventions
DRUGUsual 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.
DRUGTight 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.
Sponsors
Alisse Hauspurg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Once randomization is complete, there will be no blinding of participants, care providers or investigators. Outcomes assessors will be masked to intervention arm.
Intervention model description
The investigators will conduct a prospective single site, single-blinded, parallel randomized control trial in which individuals diagnosed with HDP will be randomized to usual care or tight blood pressure control for therapeutic intent. Subjects will undergo 3 study visits (1 in-person and 2 remote) involving BP measurements, blood draws, and/or questionnaires.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Eligible, Enrolled and Retained (Feasibility) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Anti-hypertensive Medication Use | 6 months postpartum | Number of participants with anti-hypertensive medication use |
| Anti-hypertensive Medication Use | 6 weeks postpartum | Anti-hypertensive medication use |
| Mean Arterial Pressure (Efficacy) | 6 months postpartum | Mean arterial pressure (systolic BP + 2\*diastolic BP / 3) |
| 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 |
| Diastolic Blood Pressure | 6 months postpartum | Mean diastolic blood pressure |
| Change in MAP | 6 weeks postpartum | Change in mean arterial pressure (systolic BP + 2\*diastolic BP / 3) from baseline |
| Change in Systolic BP | 6 weeks postpartum | Change in systolic BP from baseline |
| Change in Diastolic BP | 6 weeks postpartum | Change in diastolic BP from baseline |
| Number of Participants With Hospital Readmissions | Six months postpartum | Postpartum hospital readmissions |
| Number of Participants With ER Visits | Six months postpartum | Emergency room visits |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlisse K Hauspurg, MD
UPMC Magee Women's Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 30.1 years STANDARD_DEVIATION 5.1 |
| Diastolic blood pressure | 83.2 mmHg STANDARD_DEVIATION 10.1 |
| Mean arterial pressure | 100.8 mmHg STANDARD_DEVIATION 8.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 26 Participants |
| Region of Enrollment United States | 61 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 0 Participants |
| Systolic blood pressure | 126.9 mmHg STANDARD_DEVIATION 11.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 30 |
| other Total, other adverse events | 0 / 31 | 0 / 30 |
| serious Total, serious adverse events | 0 / 31 | 0 / 30 |
Outcome results
None listed