PROtecting Maternal Brains From Injury and Stroke

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Description

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

Start Date
May 4, 2023
Completion Date
December 31, 2024
Enrollment
50
Date Posted
February 13, 2023
Accepts Healthy Volunteers?
No
Gender
Female

Locations

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

Eligibility

Minimum Age (years)
18
Maximum Age (years)
55
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:

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)

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 Contact Info

Study Contact Name
Eliza Miller, MD, MS; Noora Haghighi
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
Yes
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).
NCTid (if applicable)
NCT05726279