An interventional study of Transorbital ultrasound of the optic nerve sheet in Preeclampsia Severe, sponsored by Saint Thomas Hospital, Panama. Completed at 1 site in Panama. Open to female participants aged 15 Years to 44 Years. Per ClinicalTrials.gov, last updated 2023-04-27.
Sponsored by Saint Thomas Hospital, Panama · Not applicable, Interventional, and Diagnostic
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.
882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.
This study's enrollment of 100 is close to the median of 110 across 468 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Saint Thomas Hospital, Panama is the lead sponsor of 36 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with severe preeclampsia and gestational age between 34-40 weeks.
Procedure: Transorbital ultrasound of the optic nerve sheet
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).
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.
Time frame: 24 hours
Plan to share: No
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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Saint Thomas Hospital, Panama