Optimal Blood Pressure Treatment Thresholds Postpartum

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.

• Usual care (Drug): 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.
• Tight blood pressure control (Drug), also known as Tight 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.

Primary outcomes

• 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 outcomes

• 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
• Diastolic Blood Pressure [6 weeks 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

Other outcomes

• Interval Participant Retention [6 weeks postpartum]: Number of participants retained to 6 weeks postpartum
• Participant Retention [6 months postpartum]: Retention of participants to 6 months postpartum

Sex: Female, ages: 18 Years to 55 Years

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

Participant flow

Outcome results

• Percent of Participants Eligible, Enrolled and Retained (Feasibility) (Primary), Count of participants, Participants: Enrollment 61
• Number of Participants With Anti-hypertensive Medication Use (Secondary), Count of participants, Participants: Usual Care Group 5; Intervention (Tight Blood Pressure Control) Group 1
• Anti-hypertensive Medication Use (Secondary), Count of participants, Participants: Usual Care Group 4; Intervention (Tight Blood Pressure Control) Group 5
• Mean Arterial Pressure (Efficacy) (Secondary), Mean, mmHg: Usual Care Group 92.1 +/- 7.1; Intervention (Tight Blood Pressure Control) Group 91.7 +/- 6.7
• Mean Arterial Pressure (Secondary), Mean, mmHg: Usual Care Group 97.0 +/- 11.2; Intervention (Tight Blood Pressure Control) Group 89.5 +/- 6.1
• Systolic Blood Pressure (Secondary), Mean, mmHg: Usual Care Group 120.4 +/- 13.0; Intervention (Tight Blood Pressure Control) Group 116.5 +/- 9.4
• Diastolic Blood Pressure (Secondary), Mean, mmHg: Usual Care Group 77.9 +/- 7.4; Intervention (Tight Blood Pressure Control) Group 79.3 +/- 6.5
• Diastolic Blood Pressure (Secondary), Mean, mmHg: Usual Care Group 83.8 +/- 11.3; Intervention (Tight Blood Pressure Control) Group 76.6 +/- 6.1
• Change in MAP (Secondary), Mean, mmHg: Usual Care Group -4.1 +/- 13.0; Intervention (Tight Blood Pressure Control) Group -8.4 +/- 13.0
• Change in Systolic BP (Secondary), Mean, mmHg: Usual Care Group -6.5 +/- 15.9; Intervention (Tight Blood Pressure Control) Group -10.0 +/- 16.1
• Change in Diastolic BP (Secondary), Mean, mmHg: Usual Care Group -3.0 +/- 12.6; Intervention (Tight Blood Pressure Control) Group -7.7 +/- 12.0
• Number of Participants With Hospital Readmissions (Secondary), Count of participants, Participants: Usual Care Group 0; Intervention (Tight Blood Pressure Control) Group 0
• Number of Participants With ER Visits (Secondary), Count of participants, Participants: Usual Care Group 2; Intervention (Tight Blood Pressure Control) Group 1
• Interval Participant Retention (Other pre specified), Count of participants, Participants: Usual Care Group 27; Intervention (Tight Blood Pressure Control) Group 23
• Participant Retention (Other pre specified), Count of participants, Participants: Usual Care Group 28; Intervention (Tight Blood Pressure Control) Group 21

Adverse events

Time frame: Adverse events were collected for the 6 months of the study period

• Study Protocol and Statistical Analysis Plan (PDF, 2025-02-10)

• Alisse K Hauspurg, MD, Principal investigator, UPMC Magee Women's Hospital