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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
Saint Thomas Hospital, Panama
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Preeclampsia Severe focused on measuring Severe preeclampsia, Optic nerve sheet, Intracranial pressure

Eligibility Criteria

15 Years - 44 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

First Posted
October 21, 2022
Last Updated
April 25, 2023
Sponsor
Saint Thomas Hospital, Panama
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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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