Clinical trial NCT05726279: PROtecting Maternal Brains From Injury and Stroke
Official title: PROtecting Maternal Brains From Injury and Stroke (PROMIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preeclampsia
Maternal Hypertension
Keywords: Pregnancy
Near-Infrared Spectroscopy (NIRS)
Preeclampsia
Maternal health
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-02-13
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Percentage of time mean arterial pressure (MAP) is in the target range
timeFrame: 24 hours
Secondary outcomes:
measure: Number of participants with neurological symptoms
timeFrame: 24 hours
measure: Number of participants with physiological biomarker evidence of cerebral hypoperfusion
timeFrame: 24 hours
measure: Number of participants with physiological biomarker evidence of cerebral hyperperfusion
timeFrame: 24 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center / NewYork-Presbyterian Hospital (NYP)
state: New York
Study officials:
affiliation: Columbia University
name: Eliza Miller, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: