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OpenTrials
Completed

NCT Number: NCT05594056

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

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.

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Key information

Age range

15 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saint Thomas H

Panama City, Panama

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Transorbital ultrasound of the optic nerve sheet

Procedure

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

Primary outcomes

  1. Optic nerve sheet measurement

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Saint Thomas Hospital, Panama

Other

Registry information

Official study title

Transorbital Ultrasound Measurement of Optic Nerve Sheath Diameter Between Pregnant Women With Severe Preeclampsia and Normal Gestations. Prospective, Controlled Trial.

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Oct 26, 2022
Registry last updated
Apr 27, 2023

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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