PROtecting Maternal Brains From Injury and Stroke — PROMIS  

Preeclampsia Clinical Trial

Official title: PROtecting Maternal Brains From Injury and Stroke (PROMIS)

Status Recruiting

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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Maternal Hypertension
• Pre-Eclampsia
• Preeclampsia

• NCT number: NCT05726279
• Study type: Interventional
• Source: Columbia University
• Contact: Eliza Miller, MD, MS
• Phone: 212-305-8389
• Email: ecm2137@cumc.columbia.edu
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2023
• Completion date: December 31, 2024