search
Back to results

Optic Nerve Sheath Diameter in Preeclampsia

Primary Purpose

Pre-Eclampsia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Optic nerve sheath diameter measurement
Sponsored by
Kanuni Sultan Suleyman Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pre-Eclampsia

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • History of previous intracranial pathology or surgery
  • Glaucoma

Sites / Locations

  • Kanuni Sultan Suleyman Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Preeclampsia group

Pregnants without preeclampsia

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

ICP
The difference in ICP estimated with optic nerve sheath diameter measurement among women with or without preeclampsia

Secondary Outcome Measures

Full Information

First Posted
June 30, 2019
Last Updated
February 19, 2020
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04004897
Brief Title
Optic Nerve Sheath Diameter in Preeclampsia
Official Title
Evaluation of Intracranial Pressure With Optic Nerve Sheath Diameter Measurement in Women With or Without Preeclampsia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 5, 2019 (Actual)
Primary Completion Date
November 20, 2019 (Actual)
Study Completion Date
November 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preeclampsia group
Arm Type
Other
Arm Description
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.
Arm Title
Pregnants without preeclampsia
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Optic nerve sheath diameter measurement
Intervention Description
Optic nerve sheath diameter measurement is performed with a linear ultrasound probe placed over the eyelid.
Primary Outcome Measure Information:
Title
ICP
Description
The difference in ICP estimated with optic nerve sheath diameter measurement among women with or without preeclampsia
Time Frame
At 6th hour of admission

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be diagnosed as preeclampsia Age must be > 18 years Exclusion Criteria: History of previous intracranial pathology or surgery Glaucoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huseyin Kiyak, MD
Organizational Affiliation
Kanuni Sultan Suleyman Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kanuni Sultan Suleyman Training and Research Hospital
City
Istanbul
State/Province
Please Enter The State Or Province
ZIP/Postal Code
34005
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Optic Nerve Sheath Diameter in Preeclampsia

We'll reach out to this number within 24 hrs