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

September 19, 2024 updated by: Eliza Miller MD MS, Columbia University

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center / NewYork-Presbyterian Hospital (NYP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Post-delivery preeclampsia patients
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenated hemoglobin concentration
Time Frame: Continuously collected for up to 24 hours

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
Time Frame: Continuously collected for up to 24 hours
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)
Time Frame: Continuously collected for up to 24 hours
Continuous non-invasive BP monitoring will be utilized (ClearSight finger cuff system, Edwards LifeSciences).
Continuously collected for up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Eliza Miller, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2021

Primary Completion (Actual)

March 13, 2023

Study Completion (Actual)

March 13, 2023

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

December 1, 2021

First Posted (Actual)

December 14, 2021

Study Record Updates

Last Update Posted (Actual)

September 23, 2024

Last Update Submitted That Met QC Criteria

September 19, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAT1562
  • 3K23NS107645-02S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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