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

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05155852
• Other study ID #: AAAT1562
• Secondary ID: 3K23NS107645-02S
• Status: Completed
• Start date: August 13, 2021
• Est. completion date: May 25, 2023

Study information

• Verified date: August 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 25, 2023
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia
• Preeclampsia

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center / NewYork-Presbyterian Hospital (NYP)	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Blood pressure (BP)	Continuous non-invasive BP monitoring will be utilized (ClearSight finger cuff system, Edwards LifeSciences).	Continuously collected for up to 24 hours