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Completed

NCT Number: NCT05155852

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 ...]

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 14, 2021
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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