Bedside Monitoring to Identify Impaired Cerebral Autoregulation in Women With Postpartum Hypertension

Study Overview
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Brief Summary
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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
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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.

Official Title
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NIRS-Based Bedside Monitoring to Identify Impaired Cerebral Autoregulation in Women With Postpartum Hypertension

Conditions
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Preeclampsia, Hypertension in Pregnancy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post-delivery preeclampsia patients<br>Women admitted to the high-risk unit(s) with elevated blood pressure and neurological symptoms, such as headache, after delivery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenated hemoglobin concentration | The Edwards HemoSphere system with ForeSight Elite NIRS component (Edwards LifeSciences) will be used to monitor oxygenated and deoxygenated hemoglobin concentrations. Two adhesive NIRS probes will be placed on the frontotemporal scalp covering the cortex, usually supplied by the middle cerebral artery. [Describe how the concentration will be obtained, the range of anticipated concentrations, and how to interpret the concentrations - eg, higher concentrations indicate ...] | Continuously collected for up to 24 hours | 
| Deoxygenated hemoglobin concentration | The Edwards HemoSphere system with ForeSight Elite NIRS component (Edwards LifeSciences) will be used to monitor oxygenated and deoxygenated hemoglobin concentrations. Two adhesive NIRS probes will be placed on the frontotemporal scalp covering the cortex, usually supplied by the middle cerebral artery. | Continuously collected for up to 24 hours | 
| Blood pressure (BP) | Continuous non-invasive BP monitoring will be utilized (ClearSight finger cuff system, Edwards LifeSciences). | Continuously collected for up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Near-infrared spectroscopy (NIRS), Preeclampsia, Pregnancy