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出境医 / 临床实验 / Optic Nerve Sheath Diameter in Preeclampsia

Optic Nerve Sheath Diameter in Preeclampsia

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.

Condition or disease Intervention/treatment Phase
Pre-Eclampsia Diagnostic Test: Optic nerve sheath diameter measurement Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluation of Intracranial Pressure With Optic Nerve Sheath Diameter Measurement in Women With or Without Preeclampsia
Actual Study Start Date : July 5, 2019
Actual Primary Completion Date : November 20, 2019
Actual Study Completion Date : November 25, 2019
Arms and Interventions
Arm Intervention/treatment
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.
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.
Outcome Measures
Primary Outcome Measures :
  1. ICP [ Time Frame: At 6th hour of admission ]
    The difference in ICP estimated with optic nerve sheath diameter measurement among women with or without preeclampsia


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • History of previous intracranial pathology or surgery
  • Glaucoma
Contacts and Locations

Locations
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Turkey
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Please Enter The State Or Province, Turkey, 34005
Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
Investigators
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Principal Investigator: Huseyin Kiyak, MD Kanuni Sultan Suleyman Hospital
Tracking Information
First Submitted Date  ICMJE June 30, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date February 20, 2020
Actual Study Start Date  ICMJE July 5, 2019
Actual Primary Completion Date November 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019) 		ICP [ Time Frame: At 6th hour of admission ]
The difference in ICP estimated with optic nerve sheath diameter measurement among women with or without preeclampsia
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optic Nerve Sheath Diameter in Preeclampsia
Official Title  ICMJE Evaluation of Intracranial Pressure With Optic Nerve Sheath Diameter Measurement in Women With or Without Preeclampsia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Pre-Eclampsia
Intervention  ICMJE Diagnostic Test: Optic nerve sheath diameter measurement
Optic nerve sheath diameter measurement is performed with a linear ultrasound probe placed over the eyelid.
Study Arms  ICMJE
  • 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.
    Intervention: Diagnostic Test: Optic nerve sheath diameter measurement
  • 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.
    Intervention: Diagnostic Test: Optic nerve sheath diameter measurement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2020) 		90
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2019) 		80
Actual Study Completion Date  ICMJE November 25, 2019
Actual Primary Completion Date November 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • History of previous intracranial pathology or surgery
  • Glaucoma
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04004897
Other Study ID Numbers  ICMJE Huseyin3
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Huseyin Kiyak, Kanuni Sultan Suleyman Training and Research Hospital
Study Sponsor  ICMJE Kanuni Sultan Suleyman Training and Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Huseyin Kiyak, MD Kanuni Sultan Suleyman Hospital
PRS Account Kanuni Sultan Suleyman Training and Research Hospital
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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