Clinical trial NCT05155852: Bedside Monitoring to Identify Impaired Cerebral Autoregulation in Women with Postpartum Hypertension
Official title: NIRS-Based Bedside Monitoring to Identify Impaired Cerebral Autoregulation in Women with Postpartum Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Hypertension in Pregnancy
Keywords: Near-infrared spectroscopy (NIRS)
Preeclampsia
Pregnancy
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2021-12-14
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be recruited from the high-risk inpatient obstetrics unit at NewYork-Presbyterian Hospital/Columbia University Irving Medical Center. Women who have given birth within the previous 12 weeks and are admitted to the high-risk inpatient obstetrics unit for management of hypertension will be screened.

Brief summary: The purpose of this research study is to develop a protocol for NIRS-based bedside monitoring to identify impaired cerebral autoregulation in women admitted to the high-risk obstetrics unit with postpartum hypertension. The investigators will then pilot this protocol in 10 patients with high-risk neurological features, such as headache.

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.

This is a single center feasibility study that will include up to 10 women. Postpartum women admitted to the obstetrics high-risk stepdown unit for management of postpartum hypertension will be eligible for this study. Informed consent will be obtained from participants prior to enrollment in the study.

Eligibility criteria: Inclusion Criteria:

* Women who have given birth within the previous 12 weeks
* Admitted to the high-risk inpatient obstetrics unit for management of hypertension
* With headache or other neurological symptoms such as vision changes

Exclusion Criteria:

* Acute ischemic stroke
* Intracerebral or subarachnoid hemorrhage
* Eclamptic seizures
* Any other neurological complication requiring transfer to the neurological intensive care unit or stroke stepdown unit
* History of Reynaud's syndrome

Primary outcomes:
measure: Oxygenated hemoglobin concentration
timeFrame: Continuously collected for up to 24 hours
measure: Deoxygenated hemoglobin concentration
timeFrame: Continuously collected for up to 24 hours
measure: Blood pressure (BP)
timeFrame: Continuously collected for up to 24 hours
Secondary outcomes:
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
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petersen NH, Silverman A, Strander SM, Kodali S, Wang A, Sansing LH, Schindler JL, Falcone GJ, Gilmore EJ, Jasne AS, Cord B, Hebert RM, Johnson M, Matouk CC, Sheth KN. Fixed Compared With Autoregulation-Oriented Blood Pressure Thresholds After Mechanical Thrombectomy for Ischemic Stroke. Stroke. 2020 Mar;51(3):914-921. doi: 10.1161/STROKEAHA.119.026596. Epub 2020 Feb 12.