PreeclampsiaPROMISNCT05726279
PROtecting Maternal Brains From Injury and Stroke
A study testing NIRS based personalized blood pressure management in people with Preeclampsia and Maternal Hypertension, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to test a new approach to blood pressure management in postpartum preeclampsia. There will be two groups of patients in this early stage single center trial. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Preeclampsia, Maternal Hypertension
- What is being tested?
- NIRS based personalized blood pressure management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18 or older, within 6 weeks postpartum after a pregnancy lasting at least 20 weeks.
- Admitted to the inpatient obstetrics unit for treatment of preeclampsia with one or both of the following severe features:
- measured systolic BP ≥160 mmHg and/or diastolic BP ≥110 mmHg on two or more occasions, 15 minutes apart OR
- severe headache refractory to standard over-the-counter medications (acetaminophen, ibuprofen)
Who cannot join
- Acute ischemic stroke
- Acute intracerebral or subarachnoid hemorrhage ·
- Eclamptic seizures
- Any other neurological complication requiring transfer to the neurological intensive care unit or stroke step-down unit
- Prior history of stroke, seizures, traumatic brain injury, brain surgery, encephalitis, or demyelinating brain disease
- History of Reynaud's syndrome (contraindication to finger plethysmography)
- Inability to understand and consent to the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital (NYP)
New York, New York, 10032
About this study
Official title: PROtecting Maternal Brains From Injury and Stroke (PROMIS)
The purpose of this study is to test a new approach to blood pressure management in postpartum preeclampsia. There will be two groups of patients in this early stage single center trial. Both groups of study participants (observational and interventional) will be treated with standard blood pressure medications while undergoing continuous non-invasive blood pressure and near infrared spectroscopy (NIRS) monitoring for 24 hours. The interventional group will have personalized blood pressure targets according to results of NIRS monitoring which will be updated in real time.
Read the detailed description
Maternal neurological complications are a leading cause of postpartum severe maternal morbidity and maternal mortality (SMM/MM). The lack of biomarkers to identify women at highest risk of these rare, but devastating postpartum complications, including stroke, seizures, and posterior reversible encephalopathy syndrome, has impeded efforts to prevent neurological SMM/MM.
Impaired cerebral autoregulation may be such a biomarker. Preliminary results using transcranial Doppler (TCD) based techniques to quantify cerebral autoregulation have demonstrated severely impaired cerebral autoregulation in the postpartum period in some women. However, TCD is operator dependent, and cannot be used for extended monitoring due to discomfort. In contrast, near-infrared spectroscopy (NIRS) is fully automated and can be continued for hours at the bedside. Identifying personalized blood pressure (BP) targets using NIRS has been shown to improve outcomes in acute stroke patients, another population with impaired cerebral autoregulation. However, this method has not been applied in postpartum women.
The investigators are applying this novel approach to the management of postpartum preeclampsia (PEC) in a single-center, Phase II clinical trial, PROMIS (PROtecting Maternal brains from Injury and Stroke).
- Conditions
- Preeclampsia, Maternal Hypertension
- Being tested
- NIRS based personalized blood pressure management
- Keywords
- Pregnancy, Near-Infrared Spectroscopy (NIRS), Preeclampsia, Maternal health
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS based personalized blood pressure managementDevice
In lieu of predetermined blood pressure treatment thresholds, an optimal 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.
| Study group | Role | What they receive |
|---|---|---|
| Observational Cohort (Aim 1) | No intervention | Participants treated with standard guideline-based care for 24 hours. Blood pressure treatment thresholds will be used according to standard practice parameters |
| Interventional Cohort (Aim 2) | Experimental | 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. Receives: Device: NIRS based personalized blood pressure management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Time Mean Arterial Pressure (MAP) is Outside the Target Range
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.
Measured: 24 hours
Secondary outcomes (1)
Number of Participants With Neurological Symptoms
Number 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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start4 May 2023
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Randolph S. Marshall, MD, Columbia University
- Investigators
- Eliza Miller, MD, MS, Study chair, Columbia UniversityMarshall S Randolph, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726279
- Sponsor's protocol ID
- AAAU3179
- Other IDs
- 5R21HD110992-02
- Acronym
- PROMIS
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2023
- Last updated
- 18 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kirschner M, Woolcock Martinez H, Haghighi N, Booker WA, Marshall R, Bello NA, Petersen N, Miller EC. Increased Blood Pressure Variability is Associated with More Time Spent Outside Personalized Limits of Cerebral Autoregulation in Postpartum Preeclampsia. Neurocrit Care. 2025 Dec;43(3):853-863. doi: 10.1007/s12028-025-02316-y. Epub 2025 Jul 8.
PubMed 40629211
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROtecting Maternal Brains From Injury and Stroke (PROMIS)
- ClinicalTrials.gov ID
- NCT05726279
- Acronym / sponsor ID
- PROMIS / AAAU3179
- Conditions
- Preeclampsia, Maternal Hypertension
- Keywords
- Pregnancy, Near-Infrared Spectroscopy (NIRS), Preeclampsia, Maternal health
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 4 May 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Posted 18 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test a new approach to blood pressure management in postpartum preeclampsia. There will be two groups of patients in this early stage single center trial. Both groups of study participants (observational and interventional) will be treated with standard blood pressure medications while undergoing continuous non-invasive blood pressure and near infrared spectroscopy (NIRS) monitoring for 24 hours. The interventional group will have personalized blood pressure targets according to results of NIRS monitoring which will be updated in real time.
Detailed description
Maternal neurological complications are a leading cause of postpartum severe maternal morbidity and maternal mortality (SMM/MM). The lack of biomarkers to identify women at highest risk of these rare, but devastating postpartum complications, including stroke, seizures, and posterior reversible encephalopathy syndrome, has impeded efforts to prevent neurological SMM/MM.
Impaired cerebral autoregulation may be such a biomarker. Preliminary results using transcranial Doppler (TCD) based techniques to quantify cerebral autoregulation have demonstrated severely impaired cerebral autoregulation in the postpartum period in some women. However, TCD is operator dependent, and cannot be used for extended monitoring due to discomfort. In contrast, near-infrared spectroscopy (NIRS) is fully automated and can be continued for hours at the bedside. Identifying personalized blood pressure (BP) targets using NIRS has been shown to improve outcomes in acute stroke patients, another population with impaired cerebral autoregulation. However, this method has not been applied in postpartum women.
The investigators are applying this novel approach to the management of postpartum preeclampsia (PEC) in a single-center, Phase II clinical trial, PROMIS (PROtecting Maternal brains from Injury and Stroke).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational Cohort (Aim 1) | No intervention | –Participants treated with standard guideline-based care for 24 hours. Blood pressure treatment thresholds will be used according to standard practice parameters |
| Interventional Cohort (Aim 2) | Experimental | Device: NIRS based personalized blood pressure managementAutoregulation-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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18 or older, within 6 weeks postpartum after a pregnancy lasting at least 20 weeks.
- Admitted to the inpatient obstetrics unit for treatment of preeclampsia with one or both of the following severe features:
Key exclusion criteria (7 listed)
- Acute ischemic stroke
- Acute intracerebral or subarachnoid hemorrhage ·
- Eclamptic seizures
- Any other neurological complication requiring transfer to the neurological intensive care unit or stroke step-down unit
- Prior history of stroke, seizures, traumatic brain injury, brain surgery, encephalitis, or demyelinating brain disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRS based personalized blood pressure managementIn lieu of predetermined blood pressure treatment thresholds, an optimal 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. | Device | Interventional Cohort (Aim 2) |
Primary outcome
Percentage of Time Mean Arterial Pressure (MAP) is Outside the Target Range
Time frame: 24 hours
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.
1 secondary outcome
Number of Participants With Neurological Symptoms
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40629211Kirschner M, Woolcock Martinez H, Haghighi N, Booker WA, Marshall R, Bello NA, Petersen N, Miller EC. Increased Blood Pressure Variability is Associated with More Time Spent Outside Personalized Limits of Cerebral Autoregulation in Postpartum Preeclampsia. Neurocrit Care. 2025 Dec;43(3):853-863. doi: 10.1007/s12028-025-02316-y. Epub 2025 Jul 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eliza Miller, MD, MS study chair
Columbia University
Marshall S Randolph, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIRS based personalized blood pressure management in people with Preeclampsia and Maternal Hypertension, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Time Mean Arterial Pressure (MAP) is Outside the Target Range (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05726279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.