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

Sponsor
Saint Thomas Hospital, Panama (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05594056
Collaborator
(none)
100
1
2
3.4
29.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transorbital ultrasound of the optic nerve sheet
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Diagnostic
Official Title:
Transorbital Ultrasound Measurement of Optic Nerve Sheath Diameter Between Pregnant Women With Severe Preeclampsia and Normal Gestations. Prospective, Controlled Trial.
Anticipated Study Start Date :
Oct 21, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jan 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Preeclampsia

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

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

Active Comparator: Control

Patients with normal gestations between 34-40 weeks.

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

Outcome Measures

Primary Outcome Measures

  1. Optic nerve sheet measurement [24 hours]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 44 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Saint Thomas H Panama Panama

Sponsors and Collaborators

  • Saint Thomas Hospital, Panama

Investigators

  • Study Chair: Osvaldo Reyes, MD, Saint Thomas Hospital, Panama

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Osvaldo A. Reyes T., Chairman of Research Department, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier:
NCT05594056
Other Study ID Numbers:
  • 2022-600
First Posted:
Oct 26, 2022
Last Update Posted:
Oct 26, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Osvaldo A. Reyes T., Chairman of Research Department, Saint Thomas Hospital, Panama
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2022