Optic Nerve Sheath Diameter in Preeclampsia

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

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.

Study Overview

• Status: Completed
• Conditions: Pre-Eclampsia
• Intervention / Treatment: Diagnostic test: Optic nerve sheath diameter measurement

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Please Enter The State Or Province
    • Istanbul, Please Enter The State Or Province, Turkey, 34005
      • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Must be diagnosed as preeclampsia
• Age must be > 18 years

Exclusion Criteria:

• History of previous intracranial pathology or surgery
• Glaucoma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Preeclampsia group; Patients with preeclampsia will receive optic nerve sheath diameter measurement with a linear ultrasound probe carefully and gently placed on the closed upper eyelids of patients.	Diagnostic test: Optic nerve sheath diameter measurement; Optic nerve sheath diameter measurement is performed with a linear ultrasound probe placed over the eyelid.
Other: Pregnants without preeclampsia; Pregnant women without preeclampsia will receive optic nerve sheath diameter measurement with a linear ultrasound probe carefully and gently placed on the closed upper eyelids of patients.	Diagnostic test: Optic nerve sheath diameter measurement; Optic nerve sheath diameter measurement is performed with a linear ultrasound probe placed over the eyelid.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2019
• Primary Completion (Actual): November 20, 2019
• Study Completion (Actual): November 25, 2019

Study Registration Dates

• First Submitted: June 30, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: Huseyin3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No