PROtecting Maternal Brains From Injury and Stroke

NCT ID: NCT05726279

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-04
• Study Completion Date: 2025-02-28

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Observational Cohort

Participants treated with standard guideline-based care for 24 hours. Blood pressure treatment thresholds will be used according to standard practice parameters

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventional

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.

Group Type: EXPERIMENTAL

NIRS based personalized blood pressure management

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Randolph S. Marshall, MD

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eliza Miller, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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

New York, New York, United States

Countries

United States

References

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 Jul 8. doi: 10.1007/s12028-025-02316-y. Online ahead of print.

Reference Type: DERIVED

PMID: 40629211 (View on PubMed)

Other Identifiers

5R21HD110992-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAU3179

Identifier Type: -

Identifier Source: org_study_id