Ultrasonographic Diameter of Optic Nerve Sheath in Fluid Assessment in Severe Preeclamptic Patients

January 3, 2022 updated by: Hossam Eldin Hassan Ahmed, Sohag University

Reliability of Utrasonographic Diameter of Optic Nerve Sheath in Assessment of Fluid Status in Severe Preeclamptic Patients

Changes in the optic nerve sheath diameter detected by ultrasound are considered an important manifestation of increased intracranial pressure . The normal optic nerve sheath diameter measures up to 5.0 mm and an average optic nerve sheath diameter more than 5 mm is considered abnormal and elevated intracranial pressure should be suspected.Cerebral edema have been demonstrated in 71% to 100% of magnetic resonance imaging in preeclamptic patients and an increase in optic nerve sheath diameter has been described in preeclamptic females compared to healthy pregnant females Therefore, Increased optic nerve sheath diameter can indirectly reflect the state of intracranial edema that could be a part of generalized edema of preeclampsia and it could be a possible marker of generalized tissue edema and fluid overload in these patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Sohag, Egypt, 82511
        • Recruiting
        • Hossam Eldin Hassan Ahmed Abdelghani
        • Contact:
      • Sohag, Egypt
        • Recruiting
        • Hossam Eldin Hassan Ahmed Abdelghani
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

severe preeclamptic patients (aged 18-40) after termination of pregnancy

Description

Inclusion Criteria:

  • Systolic blood pressure of 160mm Hg or higher, or diastolic blood pressure of 110mm Hg or higher on 2 occasions at least 6 hours apart on bed rest.
  • Proteinuria ≥5g in a 24 hour urine specimen or ≥3+ on 2 random urine samples collected at least 4 hours apart.
  • patient acceptance
  • Accepted mental state of the patients

Exclusion Criteria:

  • patient refusal to participate in the study
  • chronic kidney disease
  • chronic pulmonary disease
  • chronic cardiac disease
  • chronic hypertension
  • previous ocular operation and diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between optic nerve sheath diameter and extravascular lung water
Time Frame: up to 24 hours
correlation between ultrasound assessment of optic nerve sheath diameter and extravascular lung water
up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2021

Primary Completion (Anticipated)

October 6, 2022

Study Completion (Anticipated)

December 6, 2022

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

January 3, 2022

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Actual)

January 4, 2022

Last Update Submitted That Met QC Criteria

January 3, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-12-21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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