PROtecting Maternal Brains From Injury and Stroke

Preeclampsia Clinical Trial

— PROMIS  

Official title:

PROtecting Maternal Brains From Injury and Stroke (PROMIS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05726279
• Other study ID #: AAAU3179
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Columbia University
• Contact: Eliza Miller, MD, MS
• Phone: 212-305-8389
• Email: ecm2137[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Maternal Hypertension
• Pre-Eclampsia
• Preeclampsia

Intervention

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.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center / NewYork-Presbyterian Hospital (NYP)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time mean arterial pressure (MAP) is in 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 within the personalized limits of autoregulation.	24 hours
Secondary	Number of participants with neurological symptoms	Number of participants with neurological symptoms. Neurological symptoms defined as =8/10 headache pain or blurred vision.	24 hours
Secondary	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
Secondary	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