PROtecting Maternal Brains From Injury and Stroke (PROMIS)

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.

Study Overview

• Status: Terminated
• Conditions: Preeclampsia; Maternal Hypertension
• Intervention / Treatment: Device: NIRS based personalized blood pressure management

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center / NewYork-Presbyterian Hospital (NYP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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:

  1. measured systolic BP ≥160 mmHg and/or diastolic BP ≥110 mmHg on two or more occasions, 15 minutes apart OR
  2. severe headache refractory to standard over-the-counter medications (acetaminophen, ibuprofen)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Observational Cohort (Aim 1); Participants treated with standard guideline-based care for 24 hours. Blood pressure treatment thresholds will be used according to standard practice parameters
Experimental: Interventional Cohort (Aim 2); 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.	Device: NIRS based personalized blood pressure management; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Physiological Biomarker Evidence of Cerebral Hyperperfusion	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.	24 hours
Number of Participants With Physiological Biomarker Evidence of Cerebral Hypoperfusion	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.	24 hours

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Study Chair: Eliza Miller, MD, MS, Columbia University; Principal Investigator: Marshall S Randolph, MD, Columbia University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2023
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy; Preeclampsia; Maternal health; Near-Infrared Spectroscopy (NIRS)
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension; Pre-Eclampsia; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: AAAU3179; 5R21HD110992-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No