Transorbital Ultrasound of Optic Nerve Sheath Diameter Between Healthy Pregnant Women and Those With Severe Preeclampsia.

NCT05594056 | Completed

• 1 other identifier: 2022-600
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia Severe

Keywords

Severe preeclampsia; Optic nerve sheet; Intracranial pressure

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours

Study Arms (2)

Preeclampsia

EXPERIMENTAL

Patients with severe preeclampsia and gestational age between 34-40 weeks.

Procedure: Transorbital ultrasound of the optic nerve sheet

Control

ACTIVE COMPARATOR

Patients with normal gestations between 34-40 weeks.

Procedure: Transorbital ultrasound of the optic nerve sheet

Interventions

Transorbital ultrasound of the optic nerve sheet PROCEDURE

Measurement of the optic nerve sheet with a linear transducer (7,5 MHz).

Control; Preeclampsia

Eligibility Criteria

• Age: 15 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 15-44 years.
• Gestational age between 34-40 weeks of gestation.

You may not qualify if:

• Eye disease (Glaucoma, diabetic neuropathy, optic neuritis).
• Nervous disorders.
• Psychiatric disorders
• Diabetes

Sponsors & Collaborators

• Saint Thomas Hospital, Panama: lead

Study Sites (1)

Saint Thomas H

Panama City, Panama

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Osvaldo Reyes, MD

  Saint Thomas Hospital, Panama

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Research Department

Model Details: A transorbital ultrasound to measure the optic nerve sheet will be performed in patients with severe preeclampsia and then compared with normal controls.

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 26, 2022
• Study Start: October 21, 2022
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)