Optimal Blood Pressure Treatment Thresholds Postpartum

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Other: BP Threshold for medication initiation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care Group<br>Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point. | Other: BP Threshold for medication initiation<br>* The usual care group will be given anti-hypertensive medications if a subject's BP consistently exceeds 150/100 mmHg at any point. The intervention group will receive BP meds if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg.<br>|
| Experimental: Intervention (Tight Blood Pressure Control) Group<br>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. | Other: BP Threshold for medication initiation<br>* The usual care group will be given anti-hypertensive medications if a subject's BP consistently exceeds 150/100 mmHg at any point. The intervention group will receive BP meds if a subject's hospital BP consistently exceeds 140/90 mmHg or her home BP consistently exceeds 135/85 mmHg.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension