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

NCT05155852 | Completed

• 2 other identifiers: AAAT15623K23NS107645-02S1
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia; Hypertension in Pregnancy

Keywords

Near-infrared spectroscopy (NIRS); Preeclampsia; Pregnancy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Post-delivery preeclampsia patients

Women admitted to the high-risk unit(s) with elevated blood pressure and neurological symptoms, such as headache, after delivery.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital (NYP)

New York, New York, 10032, United States

Location

Related 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.

  PMID: 32078493 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eliza Miller, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology in the Division of Stroke and Cerebrovascular Disease

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 14, 2021
• Study Start: August 13, 2021
• Primary Completion: March 13, 2023
• Study Completion: March 13, 2023
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)