PROtecting Maternal Brains From Injury and Stroke

PROtecting Maternal Brains From Injury and Stroke (PROMIS)

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05726279

Acronym

PROMIS

Enrollment

Registered

2023-02-13

Start date

2023-05-04

Completion date

2025-02-28

Last updated

2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal Hypertension, Preeclampsia

Keywords

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

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).

Interventions

DEVICENIRS 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Time Mean Arterial Pressure (MAP) is Outside the Target Range	24 hours	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.

Secondary

Measure	Time frame	Description
Number of Participants With Neurological Symptoms	24 hours	Number of participants with neurological symptoms. Neurological symptoms are defined as ≥ 8 out of 10 headache pain (on a self-reported scale of 0 to 10, where a higher score indicates greater pain) or blurred vision.

Countries

United States

Contacts

STUDY_CHAIREliza Miller, MD, MS

Columbia University

PRINCIPAL_INVESTIGATORMarshall S Randolph, MD