Trial Outcomes & Findings for Optimal Blood Pressure Treatment Thresholds Postpartum (NCT NCT06069102)
NCT ID: NCT06069102
Last Updated: 2026-06-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
61 participants
Primary outcome timeframe
Baseline to approximately 6 months postpartum, a total of 6 months postpartum
Results posted on
2026-06-02
Participant Flow
Participant milestones
| Measure |
Usual Care Group
Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.
Usual 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.
|
Intervention (Tight Blood Pressure Control) Group
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.
Tight 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.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
|
Overall Study
COMPLETED
|
28
|
21
|
|
Overall Study
NOT COMPLETED
|
3
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimal Blood Pressure Treatment Thresholds Postpartum
Baseline characteristics by cohort
| Measure |
Usual Care Group
n=31 Participants
Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.
Usual 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.
|
Intervention (Tight Blood Pressure Control) Group
n=30 Participants
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.
Tight 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.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.0 years
STANDARD_DEVIATION 5.6 • n=9 Participants
|
30.1 years
STANDARD_DEVIATION 4.8 • n=27 Participants
|
30.1 years
STANDARD_DEVIATION 5.1 • n=267 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=9 Participants
|
30 Participants
n=27 Participants
|
61 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
11 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=9 Participants
|
26 Participants
n=27 Participants
|
48 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=9 Participants
|
30 participants
n=27 Participants
|
61 participants
n=267 Participants
|
|
Systolic blood pressure
|
129.6 mmHg
STANDARD_DEVIATION 9.7 • n=9 Participants
|
124.1 mmHg
STANDARD_DEVIATION 12.3 • n=27 Participants
|
126.9 mmHg
STANDARD_DEVIATION 11.3 • n=267 Participants
|
|
Diastolic blood pressure
|
86.4 mmHg
STANDARD_DEVIATION 8.5 • n=9 Participants
|
83.2 mmHg
STANDARD_DEVIATION 10.1 • n=27 Participants
|
84.8 mmHg
STANDARD_DEVIATION 9.4 • n=267 Participants
|
|
Mean arterial pressure
|
100.8 mmHg
STANDARD_DEVIATION 8.1 • n=9 Participants
|
96.8 mmHg
STANDARD_DEVIATION 10.0 • n=27 Participants
|
98.8 mmHg
STANDARD_DEVIATION 9.2 • n=267 Participants
|
PRIMARY outcome
Timeframe: Baseline to approximately 6 months postpartum, a total of 6 months postpartumPopulation: Number of participants approached for enrollment
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.
Outcome measures
| Measure |
Usual Care Group
n=143 Participants
Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.
Usual 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.
|
Intervention (Tight Blood Pressure Control) Group
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.
Tight 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.
|
|---|---|---|
|
Percent of Participants Eligible, Enrolled and Retained (Feasibility)
|
61 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 months postpartumNumber of participants with anti-hypertensive medication use
Outcome measures
| Measure |
Usual Care Group
n=28 Participants
Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.
Usual 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.
|
Intervention (Tight Blood Pressure Control) Group
n=21 Participants
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.
Tight 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.
|
|---|---|---|
|
Number of Participants With Anti-hypertensive Medication Use
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 weeks postpartumAnti-hypertensive medication use
Outcome measures
| Measure |
Usual Care Group
n=27 Participants
Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.
Usual 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.
|
Intervention (Tight Blood Pressure Control) Group
n=23 Participants
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.
Tight 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.
|
|---|---|---|
|
Anti-hypertensive Medication Use
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6 months postpartumMean arterial pressure (systolic BP + 2\*diastolic BP / 3)
Outcome measures
| Measure |
Usual Care Group
n=28 Participants
Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.
Usual 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.
|
Intervention (Tight Blood Pressure Control) Group
n=21 Participants
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.
Tight 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.
|
|---|---|---|
|
Mean Arterial Pressure (Efficacy)
|
92.1 mmHg
Standard Deviation 7.1
|
91.7 mmHg
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: 6 weeks postpartumMean arterial pressure (systolic BP + 2\*diastolic BP / 3)
Outcome measures
| Measure |
Usual Care Group
n=27 Participants
Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.
Usual 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.
|
Intervention (Tight Blood Pressure Control) Group
n=23 Participants
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.
Tight 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.
|
|---|---|---|
|
Mean Arterial Pressure
|
97.0 mmHg
Standard Deviation 11.2
|
89.5 mmHg
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: 6 months postpartumMean systolic blood pressure
Outcome measures
| Measure |
Usual Care Group
n=28 Participants
Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.
Usual 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.
|
Intervention (Tight Blood Pressure Control) Group
n=21 Participants
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.
Tight 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.
|
|---|---|---|
|
Systolic Blood Pressure
|
120.4 mmHg
Standard Deviation 13.0
|
116.5 mmHg
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: 6 months postpartumMean diastolic blood pressure
Outcome measures
| Measure |
Usual Care Group
n=28 Participants
Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.
Usual 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.
|
Intervention (Tight Blood Pressure Control) Group
n=21 Participants
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.
Tight 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.
|
|---|---|---|
|
Diastolic Blood Pressure
|
77.9 mmHg
Standard Deviation 7.4
|
79.3 mmHg
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: 6 weeks postpartumMean diastolic blood pressure
Outcome measures
| Measure |
Usual Care Group
n=27 Participants
Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.
Usual 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.
|
Intervention (Tight Blood Pressure Control) Group
n=23 Participants
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.
Tight 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.
|
|---|---|---|
|
Diastolic Blood Pressure
|
83.8 mmHg
Standard Deviation 11.3
|
76.6 mmHg
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: 6 weeks postpartumChange in mean arterial pressure (systolic BP + 2\*diastolic BP / 3) from baseline
Outcome measures
| Measure |
Usual Care Group
n=27 Participants
Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.
Usual 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.
|
Intervention (Tight Blood Pressure Control) Group
n=23 Participants
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.
Tight 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.
|
|---|---|---|
|
Change in MAP
|
-4.1 mmHg
Standard Deviation 13.0
|
-8.4 mmHg
Standard Deviation 13.0
|
SECONDARY outcome
Timeframe: 6 weeks postpartumChange in systolic BP from baseline
Outcome measures
| Measure |
Usual Care Group
n=27 Participants
Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.
Usual 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.
|
Intervention (Tight Blood Pressure Control) Group
n=23 Participants
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.
Tight 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.
|
|---|---|---|
|
Change in Systolic BP
|
-6.5 mmHg
Standard Deviation 15.9
|
-10.0 mmHg
Standard Deviation 16.1
|
SECONDARY outcome
Timeframe: 6 weeks postpartumChange in diastolic BP from baseline
Outcome measures
| Measure |
Usual Care Group
n=27 Participants
Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.
Usual 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.
|
Intervention (Tight Blood Pressure Control) Group
n=23 Participants
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.
Tight 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.
|
|---|---|---|
|
Change in Diastolic BP
|
-3.0 mmHg
Standard Deviation 12.6
|
-7.7 mmHg
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: Six months postpartumPostpartum hospital readmissions
Outcome measures
| Measure |
Usual Care Group
n=31 Participants
Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.
Usual 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.
|
Intervention (Tight Blood Pressure Control) Group
n=30 Participants
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.
Tight 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.
|
|---|---|---|
|
Number of Participants With Hospital Readmissions
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Six months postpartumEmergency room visits
Outcome measures
| Measure |
Usual Care Group
n=31 Participants
Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.
Usual 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.
|
Intervention (Tight Blood Pressure Control) Group
n=30 Participants
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.
Tight 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.
|
|---|---|---|
|
Number of Participants With ER Visits
|
2 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeks postpartumNumber of participants retained to 6 weeks postpartum
Outcome measures
| Measure |
Usual Care Group
n=31 Participants
Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.
Usual 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.
|
Intervention (Tight Blood Pressure Control) Group
n=30 Participants
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.
Tight 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.
|
|---|---|---|
|
Interval Participant Retention
|
27 Participants
|
23 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months postpartumRetention of participants to 6 months postpartum
Outcome measures
| Measure |
Usual Care Group
n=31 Participants
Standard of care BP medication will usually be started if a subject's BP consistently exceeds 150/100 mmHg at any point.
Usual 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.
|
Intervention (Tight Blood Pressure Control) Group
n=30 Participants
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.
Tight 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.
|
|---|---|---|
|
Participant Retention
|
28 Participants
|
21 Participants
|
Adverse Events
Usual Care Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention (Tight Blood Pressure Control) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Alisse Hauspurg, MD
University of Pittsburgh, Brown University
Phone: 401-274-1122
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place