NCT03556267

Brief Summary

Beta trace protein assay is an indicator of post-spinal CSF leak that predicts the degree of post-spinal headache.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

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

May 19, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 14, 2018

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 14, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2021

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

1.2 years

First QC Date

May 19, 2018

Last Update Submit

February 15, 2021

Conditions

Anesthesia, Obestetric

Outcome Measures

Primary Outcomes (1)

  • CSF sample: serum sample

    After insertion of an intravenous line 4 ml serum will be collected, then 0.5 ml CSF sample will be collected after insertion of the dura by the selected spinal needle before injecting the anesthetic drugs used for spinal anesthesia. Beta trace protein assay will be measured through ELISA technique in both CSF and serum samples and the ratio will be calculated and measured. This ratio will be measured for the three arms aiming at the comparison between the three devices regarding the CSF : Serum ratio.

    One year

Study Arms (2)

spinal needle 27 gauqge

OTHER

It is a device used to penetrate the dura to take CSF sample before injecting the drugs used for spinal anesthesia for cesarean section.

Device: spinal needle

spinal needle 25 gauage

OTHER

It is a device used to penetrate the dura to take CSF sample before injecting the drugs used for spinal anesthesia for cesarean section.

Device: spinal needle

Interventions

spinal needleDEVICE

It is a spinal needle with 'QUINCKE' Bevel. It is inserted in the lumbar region at the inter-space L4-L5, L4-L3 ,or L3-L2 lumber spaces, while the patient is put in the sitting position then CSF sample is taken then 2.5 ml of a local anesthetic(0.5 ml of 25 ug fentanyl and 2 ml of 8 mg heavy bupivacaine) is given intrathecal then the needle is withdrawn.

spinal needle 25 gauagespinal needle 27 gauqge

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • free medical history.
  • free obstetric history.

You may not qualify if:

  • high risk pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abdelrahman

Cairo, 11562, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 19, 2018

First Posted

June 14, 2018

Study Start

August 14, 2019

Primary Completion

October 30, 2020

Study Completion

February 14, 2021

Last Updated

February 16, 2021

Record last verified: 2021-02

Locations

EG(1)