Transorbital Ultrasound of Optic Nerve Sheath Diameter Between Healthy Pregnant Women and Those With Severe Preeclampsia.
Primary Purpose
Preeclampsia Severe
Status
Completed
Phase
Not Applicable
Locations
Panama
Study Type
Interventional
Intervention
Transorbital ultrasound of the optic nerve sheet
Sponsored by
About this trial
This is an interventional diagnostic trial for Preeclampsia Severe focused on measuring Severe preeclampsia, Optic nerve sheet, Intracranial pressure
Eligibility Criteria
Inclusion Criteria:
- Age between 15-44 years.
- Gestational age between 34-40 weeks of gestation.
Exclusion Criteria:
- Eye disease (Glaucoma, diabetic neuropathy, optic neuritis).
- Nervous disorders.
- Psychiatric disorders
- Diabetes
Sites / Locations
- Saint Thomas H
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Preeclampsia
Control
Arm Description
Patients with severe preeclampsia and gestational age between 34-40 weeks.
Patients with normal gestations between 34-40 weeks.
Outcomes
Primary Outcome Measures
Optic nerve sheet measurement
The diameter of the optic nerve sheath was measured three millimeters behind the eyeball, and one axis perpendicular to the optic nerve. Three measurements were taken in each eye. The resulting six measurements were averaged to give a mean of the optic nerve sheet measurement, to minimize measurement variability.
Secondary Outcome Measures
Full Information
NCT ID
NCT05594056
First Posted
October 21, 2022
Last Updated
April 25, 2023
Sponsor
Saint Thomas Hospital, Panama
1. Study Identification
Unique Protocol Identification Number
NCT05594056
Brief Title
Transorbital Ultrasound of Optic Nerve Sheath Diameter Between Healthy Pregnant Women and Those With Severe Preeclampsia.
Official Title
Transorbital Ultrasound Measurement of Optic Nerve Sheath Diameter Between Pregnant Women With Severe Preeclampsia and Normal Gestations. Prospective, Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 21, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
January 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Thomas Hospital, Panama
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The neurological alterations associated with preeclampsia depend on cerebral autoregulation, a theory that outlines the mechanisms by which the nervous system controls cerebral perfusion. However, with the loss of autoregulation, increased blood flow, edema and eventually increased intracranial pressure are triggered and may be translated into neurological manifestations such as symptoms of vasospasm, one of the criteria for severity in preeclampsia.
Nervous system manifestations frequently found in preeclampsia are headache, blurred vision, scotomas and hyperreflexia. Although uncommon, temporary blindness (lasting a few hours to a week) may also accompany severe preeclampsia and eclampsia.
The optic nerve, as part of the central nervous system, is surrounded by cerebrospinal fluid and dura mater, which forms the optic nerve sheath. Due to the connection with the intracranial subarachnoid space, the diameter of the optic nerve sheath is influenced by variations in cerebrospinal fluid pressure. Increased intracranial pressure is transmitted to the subarachnoid space surrounding the optic nerve, causing its expansion.
Recent studies suggest that an optic nerve sheath diameter greater than 5 mm correlates 100% with ICP (intracerebral pressure) greater than 20 mm Hg. Due to the simple nature of the test and the limited time required to perform it, it is an ideal non-invasive test to assess changes in mental status, severe headache, and to take the necessary measures aimed at reducing intracranial pressure.
The diagnosis of elevated intracranial pressure is challenging and critical, because early recognition and treatment are essential to prevent brain damage or death since preeclampsia with severe data remains one of the most frequent complications in our institution.
These values are not taken from the obstetric population, so this study proposes the description of a standard value for the pregnant population. There are few studies that describe a value to help us define cases of this pathology and correlate it with the signs and symptoms of severity in patients with preeclampsia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia Severe
Keywords
Severe preeclampsia, Optic nerve sheet, Intracranial pressure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A transorbital ultrasound to measure the optic nerve sheet will be performed in patients with severe preeclampsia and then compared with normal controls.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preeclampsia
Arm Type
Experimental
Arm Description
Patients with severe preeclampsia and gestational age between 34-40 weeks.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients with normal gestations between 34-40 weeks.
Intervention Type
Procedure
Intervention Name(s)
Transorbital ultrasound of the optic nerve sheet
Intervention Description
Measurement of the optic nerve sheet with a linear transducer (7,5 MHz).
Primary Outcome Measure Information:
Title
Optic nerve sheet measurement
Description
The diameter of the optic nerve sheath was measured three millimeters behind the eyeball, and one axis perpendicular to the optic nerve. Three measurements were taken in each eye. The resulting six measurements were averaged to give a mean of the optic nerve sheet measurement, to minimize measurement variability.
Time Frame
24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 15-44 years.
Gestational age between 34-40 weeks of gestation.
Exclusion Criteria:
Eye disease (Glaucoma, diabetic neuropathy, optic neuritis).
Nervous disorders.
Psychiatric disorders
Diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osvaldo Reyes, MD
Organizational Affiliation
Saint Thomas Hospital, Panama
Official's Role
Study Chair
Facility Information:
Facility Name
Saint Thomas H
City
Panama
Country
Panama
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transorbital Ultrasound of Optic Nerve Sheath Diameter Between Healthy Pregnant Women and Those With Severe Preeclampsia.
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