Optic Nerve Sheath Diameter in Preeclampsia

NCT ID: NCT04004897

Last Updated: 2020-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-05

Study Completion Date

2019-11-25

Brief Summary

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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

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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.

Conditions

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Pre-Eclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type OTHER

Optic nerve sheath diameter measurement

Intervention Type DIAGNOSTIC_TEST

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

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.

Group Type OTHER

Optic nerve sheath diameter measurement

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Optic nerve sheath diameter measurement

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Must be diagnosed as preeclampsia
* Age must be \> 18 years

Exclusion Criteria

* History of previous intracranial pathology or surgery
* Glaucoma
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Huseyin Kiyak

Principal Investigator, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huseyin Kiyak, MD

Role: PRINCIPAL_INVESTIGATOR

Kanuni Sultan Suleyman Hospital

Locations

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Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Please Enter the State Or Province, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Huseyin3

Identifier Type: -

Identifier Source: org_study_id

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