# PROtecting Maternal brains from Injury and Stroke (PROMIS): a Single-center Phase 2 Clinical Trial

> **NIH NIH R21** · COLUMBIA UNIVERSITY HEALTH SCIENCES · 2024 · $205,625

## Abstract

PROJECT SUMMARY/ABSTRACT
Preeclampsia (PEC) affects 1 in 20 pregnancies and is a leading cause of severe maternal morbidity and
mortality. Life-threatening neurological complications of PEC include intracerebral hemorrhage, cerebral
edema, cerebral vasospasm, and ischemic stroke. Most maternal deaths due to PEC-associated
cerebrovascular complications occur postpartum. Despite this, clinical research has primarily focused on
antepartum blood pressure (BP) treatment, rather than postpartum. Current BP management guidelines for
postpartum patients recommend absolute thresholds for treatment, without accounting for factors such as
degree or rapidity of change from patients’ baseline BP. Clinicians urgently need better methods to 1) identify
individuals at risk for these devastating postpartum complications, and 2) guide BP management using
personalized, precise targets optimized for brain protection. Normal brain function requires constant cerebral
blood flow (CBF). Cerebral arterioles respond actively in response to fluctuations in BP, protecting the brain
from acute injury due to hypo- or hyper-perfusion, a phenomenon known as cerebral autoregulation. Changes
in cerebral autoregulation contribute to the pathophysiology of postpartum cerebrovascular complications. In
individuals with impaired autoregulation, targeting BP parameters to optimize cerebral perfusion could help
reduce the risk of ischemia, elevated intracranial pressure, cerebral edema and intracerebral hemorrhage.
Near-infrared spectroscopy (NIRS) is a non-invasive bedside monitoring modality that measures brain tissue
oxygenation as a proxy for CBF. The use of NIRS-based autoregulation-guided BP targets improves clinical
outcomes in neurologically injured patients. We propose to apply this novel approach to the management of
postpartum PEC (within 6 weeks of delivery) in a single-center, Phase II clinical trial, PROMIS (PROtecting
Maternal brains from Injury and Stroke). We will use NIRS monitoring to calculate personalized limits of
cerebral autoregulation in 20 individuals with postpartum preeclampsia with severe features (Aim 1); and pilot
the use of autoregulation-guided BP goals for postpartum preeclampsia with severe features in an additional
20 individuals (Aim 2). We hypothesize that: 1) standard guideline-based BP management for postpartum PEC
over 24 hours will result in ≥ 10% of time during which BP exceeds personalized upper or lower limits of
autoregulation; 2) more time with BP outside personalized limits of autoregulation will be associated with a)
increased neurological symptoms and b) objective evidence of cerebral hypo- or hyper-perfusion by NIRS; and
3) targeted BP management using autoregulation-guided goals will result in fewer neurological symptoms and
less time spent outside limits of autoregulation, compared with patients treated according to current guidelines.
This novel, high-risk, high-reward trial will be the first early phase interventional neuro-obstetri...

## Key facts

- **NIH application ID:** 10799634
- **Project number:** 5R21HD110992-02
- **Recipient organization:** COLUMBIA UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** Eliza C Miller
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $205,625
- **Award type:** 5
- **Project period:** 2023-03-02 → 2026-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10799634

## Citation

> US National Institutes of Health, RePORTER application 10799634, PROtecting Maternal brains from Injury and Stroke (PROMIS): a Single-center Phase 2 Clinical Trial (5R21HD110992-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10799634. Licensed CC0.

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