NCT04301830

Brief Summary

This is observational study. The investigator will measure optic nerve sheath diameter by ultrasound on the eye after cesarean section under spinal anesthesia.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 6, 2020

Last Update Submit

March 6, 2020

Conditions

Intracranial Hypotension

Outcome Measures

Primary Outcomes (1)

  • Change optic nerve sheath diameter

    Change in Optic nerve sheathe diameter from baseline, 1,,6,24 and 48 hours after completion of surgery

    0,1,6,24 and 48 hours

Study Arms (1)

Spinal anesthesia

Patients undergoing cesarean section under spinal anesthesia

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing cesarean section under spinal anesthesia.

You may qualify if:

  • Patients undergoing cesarean section under spinal anesthesia

You may not qualify if:

  • Patients who did not agree to participate in the study
  • Patients has ophthalmic diseases
  • Patients has previous history of ophthalmic surgery.
  • Patients has neurological disorders.
  • Patients has history of head surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Watanabe A, Horikoshi T, Uchida M, Ishigame K, Kinouchi H. Decreased diameter of the optic nerve sheath associated with CSF hypovolemia. AJNR Am J Neuroradiol. 2008 May;29(5):863-4. doi: 10.3174/ajnr.A1027. Epub 2008 Feb 29.

    PMID: 18310231BACKGROUND

  • Bauerle J, Gizewski ER, Stockhausen Kv, Rosengarten B, Berghoff M, Grams AE, Kaps M, Nedelmann M. Sonographic assessment of the optic nerve sheath and transorbital monitoring of treatment effects in a patient with spontaneous intracranial hypotension: case report. J Neuroimaging. 2013 Apr;23(2):237-9. doi: 10.1111/j.1552-6569.2011.00640.x. Epub 2011 Sep 1.

    PMID: 21883624BACKGROUND

MeSH Terms

Conditions

Intracranial Hypotension

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 10, 2020

Study Start

April 1, 2020

Primary Completion

April 1, 2021

Study Completion

April 1, 2022

Last Updated

March 10, 2020

Record last verified: 2020-03