Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 76 of 152 for:    severe preeclampsia AND Pregnancy Complications

Optic Nerve Sheath Diameter in Preeclampsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04004897
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Huseyin Kiyak, Kanuni Sultan Suleyman Training and Research Hospital

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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
Estimated Primary Completion Date : September 20, 2019
Estimated Study Completion Date : September 25, 2019

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004897


Contacts
Layout table for location contacts
Contact: Huseyin Kiyak, MD +902124041500 hsynkyk@gmail.com
Contact: Gulseren Yilmaz, MD +902124041500 drgulseren83@gmail.com

Locations
Layout table for location information
Turkey
Kanuni Sultan Suleyman Training and Research Hospital Recruiting
Istanbul, Please Enter The State Or Province, Turkey, 34005
Contact: Hüseyin Kiyak, M.D.    2124041500    hsynkyk@gmail.com   
Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
Investigators
Layout table for investigator information
Principal Investigator: Huseyin Kiyak, MD Kanuni Sultan Suleyman Hospital

Layout table for additonal information
Responsible Party: Huseyin Kiyak, Principal Investigator, M.D., Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04004897     History of Changes
Other Study ID Numbers: Huseyin3
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications