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NCT04004897 Clinical Trial

Optic Nerve Sheath Diameter in Preeclampsia

Pre-Eclampsia Clinical Trial

Official title:
Evaluation of Intracranial Pressure With Optic Nerve Sheath Diameter Measurement in Women With or Without Preeclampsia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04004897
Other study ID # Huseyin3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 5, 2019
Est. completion date November 25, 2019

Study information
Verified date February 2020
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Severe preeclampsia is associated with an elevation in intracranial pressure (ICP). Optic nerve sheath diameter is a non-invasive surrogate of invasive ICP measurement. This study targets to evaluate the ICP in patients with or without preeclampsia.

Description:

MRI studies have shown that brain edema due to an elevation in ICP develops in up to 70% of women with preeclampsia. Optic nerve sheath diameter is used to estimate the ICP and has been shown to correlate well with invasive ICP measurement. The present study aims to compare ICP using optic nerve sheath diameter in women with or without preeclampsia.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date November 25, 2019
Est. primary completion date November 20, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria:

- Must be diagnosed as preeclampsia

- Age must be > 18 years

Exclusion Criteria:

- History of previous intracranial pathology or surgery

- Glaucoma

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Optic nerve sheath diameter measurement
Optic nerve sheath diameter measurement is performed with a linear ultrasound probe placed over the eyelid.

Locations
Country Name City State
Turkey Kanuni Sultan Suleyman Training and Research Hospital Istanbul Please Enter The State Or Province

Sponsors (1)
Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary ICP The difference in ICP estimated with optic nerve sheath diameter measurement among women with or without preeclampsia At 6th hour of admission
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