Trial Outcomes & Findings for PROtecting Maternal Brains From Injury and Stroke (NCT NCT05726279)
NCT ID: NCT05726279
Last Updated: 2026-03-18
Results Overview
The total time (in minutes) each participant had their mean arterial blood pressure (MAP) values within their computed limits of autoregulation will be measured. The primary outcome is the percentage of time the MAP is outside the personalized limits of autoregulation.
TERMINATED
NA
26 participants
24 hours
2026-03-18
Participant Flow
Participant milestones
| Measure |
Observational Cohort
Participants treated with standard guideline-based care for 24 hours. Blood pressure treatment thresholds will be used according to standard practice parameters
|
Interventional Cohort
Autoregulation-guided blood pressure management for 24 hours. Blood pressure will be measured every four hours by arm cuff; however, in lieu of predetermined blood pressure treatment thresholds, an optimal mean arterial pressure (MAP) range will be chosen based on limits of autoregulation calculated in real-time for the previous four hours for each participant. Choice of medications and dosing will be left to the primary clinical obstetrics team.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
1
|
|
Overall Study
COMPLETED
|
25
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PROtecting Maternal Brains From Injury and Stroke
Baseline characteristics by cohort
| Measure |
Observational Cohort
n=25 Participants
Participants treated with standard guideline-based care for 24 hours. Blood pressure treatment thresholds will be used according to standard practice parameters
|
Interventional Cohort
Autoregulation-guided blood pressure management for 24 hours. Blood pressure will be measured every four hours by arm cuff; however, in lieu of predetermined blood pressure treatment thresholds, an optimal mean arterial pressure (MAP) range will be chosen based on limits of autoregulation calculated in real-time for the previous four hours for each participant. Choice of medications and dosing will be left to the primary clinical obstetrics team.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=110 Participants
|
—
|
0 Participants
n=224 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=110 Participants
|
—
|
25 Participants
n=224 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=110 Participants
|
—
|
0 Participants
n=224 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=110 Participants
|
—
|
25 Participants
n=224 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=110 Participants
|
—
|
0 Participants
n=224 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=110 Participants
|
—
|
6 Participants
n=224 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
5 Participants
n=110 Participants
|
—
|
5 Participants
n=224 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
14 Participants
n=110 Participants
|
—
|
14 Participants
n=224 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=110 Participants
|
—
|
25 Participants
n=224 Participants
|
|
Medical comorbidities
Pre-gravida obesity
|
11 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
11 Participants
n=224 Participants
|
|
Medical comorbidities
Chronic hypertension
|
12 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
12 Participants
n=224 Participants
|
|
Medical comorbidities
History of migraine headache
|
14 Participants
n=110 Participants
|
0 Participants
n=114 Participants
|
14 Participants
n=224 Participants
|
|
Pregnancy characteristics
Primiparous
|
11 Participants
n=110 Participants
|
—
|
11 Participants
n=224 Participants
|
|
Pregnancy characteristics
Fetal growth restriction
|
5 Participants
n=110 Participants
|
—
|
5 Participants
n=224 Participants
|
|
Pregnancy characteristics
Gestational hypertension
|
5 Participants
n=110 Participants
|
—
|
5 Participants
n=224 Participants
|
|
Pregnancy characteristics
Postpartum hemorrhage
|
5 Participants
n=110 Participants
|
—
|
5 Participants
n=224 Participants
|
|
Delivery type
Vaginal delivery
|
11 Participants
n=110 Participants
|
—
|
11 Participants
n=224 Participants
|
|
Delivery type
Cesarean section
|
14 Participants
n=110 Participants
|
—
|
14 Participants
n=224 Participants
|
|
Any adverse pregnancy outcome in a prior pregnancy
Hypertensive disorder of pregnancy
|
7 Participants
n=110 Participants
|
—
|
7 Participants
n=224 Participants
|
|
Any adverse pregnancy outcome in a prior pregnancy
Preterm delivery
|
5 Participants
n=110 Participants
|
—
|
5 Participants
n=224 Participants
|
|
Days postpartum at the time of study enrollment
|
5.5 days
n=110 Participants
|
—
|
5.51 days
n=224 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: In the observational arm, data from five participants were unusable due to too little time connected (n=1) or data was corrupted during transfer from monitoring system (n=4).
The total time (in minutes) each participant had their mean arterial blood pressure (MAP) values within their computed limits of autoregulation will be measured. The primary outcome is the percentage of time the MAP is outside the personalized limits of autoregulation.
Outcome measures
| Measure |
Observational Cohort
n=20 Participants
Participants treated with standard guideline-based care for 24 hours. Blood pressure treatment thresholds will be used according to standard practice parameters
|
Interventional Cohort
n=1 Participants
Autoregulation-guided blood pressure management for 24 hours. Blood pressure will be measured every four hours by arm cuff; however, in lieu of predetermined blood pressure treatment thresholds, an optimal mean arterial pressure (MAP) range will be chosen based on limits of autoregulation calculated in real-time for the previous four hours for each participant. Choice of medications and dosing will be left to the primary clinical obstetrics team.
|
|---|---|---|
|
Percentage of Time Mean Arterial Pressure (MAP) is Outside the Target Range
|
22.12 percent
Interval 15.3 to 26.1
|
10.12 percent
Inter-Quartile Range cannot be calculated from a single data point.
|
SECONDARY outcome
Timeframe: 24 hoursNumber of participants with neurological symptoms. Neurological symptoms are defined as ≥ 8 out of 10 headache pain (on a self-reported scale of 0 to 10, where a higher score indicates greater pain) or blurred vision.
Outcome measures
| Measure |
Observational Cohort
n=20 Participants
Participants treated with standard guideline-based care for 24 hours. Blood pressure treatment thresholds will be used according to standard practice parameters
|
Interventional Cohort
n=1 Participants
Autoregulation-guided blood pressure management for 24 hours. Blood pressure will be measured every four hours by arm cuff; however, in lieu of predetermined blood pressure treatment thresholds, an optimal mean arterial pressure (MAP) range will be chosen based on limits of autoregulation calculated in real-time for the previous four hours for each participant. Choice of medications and dosing will be left to the primary clinical obstetrics team.
|
|---|---|---|
|
Number of Participants With Neurological Symptoms
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hoursPopulation: Data was not analyzed for this outcome due to early termination of the study.
Tissue oxygenation index (TOI) is defined as the ratio of oxygenated to total tissue hemoglobin as measured by NIRS. After initial securing of Foresight cerebral forehead oximetry adhesive stickers, baseline TOI will be recorded after two minutes of monitoring. Hyperperfusion will be defined as a \>2% increase from baseline TOI.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hoursPopulation: Data was not analyzed for this outcome due to early termination of the study.
Tissue oxygenation index (TOI) is defined as the ratio of oxygenated to total tissue hemoglobin as measured by NIRS. After initial securing of Foresight cerebral forehead oximetry adhesive stickers, baseline TOI will be recorded after two minutes of monitoring. Hypoperfusion will be defined as \>13% decrease from baseline TOI.
Outcome measures
Outcome data not reported
Adverse Events
Observational Cohort
Interventional Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Eliza Miller, MD MS, Adjunct Associate Professor of Neurology
Columbia University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place