PROtecting Maternal Brains From Injury and Stroke

NCT05726279 | Terminated Results DMC FDA Device

• 2 other identifiers: AAAU31795R21HD110992-02
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Preeclampsia; Maternal Hypertension

Keywords

Pregnancy; Near-Infrared Spectroscopy (NIRS); Preeclampsia; Maternal health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With Neurological Symptoms

  24 hours

Other Outcomes (2)

• Number of Participants With Physiological Biomarker Evidence of Cerebral Hyperperfusion

  24 hours

• Number of Participants With Physiological Biomarker Evidence of Cerebral Hypoperfusion

  24 hours

Study Arms (2)

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.

Device: NIRS based personalized blood pressure management

Interventions

NIRS based personalized blood pressure management DEVICE

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.

Interventional Cohort (Aim 2)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital (NYP)

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 40629211 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Eliza Miller, MD MS, Adjunct Associate Professor of Neurology
• Organization: Columbia University

ecm2137@cumc.columbia.edu

212-305-8389

Study Officials

• Eliza Miller, MD, MS

  Columbia University

  STUDY CHAIR

• Marshall S Randolph, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 13, 2023
• Study Start: May 4, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: March 18, 2026
• Results First Posted: March 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)