NCT04187846

Brief Summary

Evaluation of the relationship between postspinal headache and near infrared spectroscopy in cesarean section patients

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 15, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
Last Updated

December 5, 2019

Status Verified

December 1, 2019

Enrollment Period

10 months

First QC Date

December 2, 2019

Last Update Submit

December 4, 2019

Conditions

Tissue Oxygenation

Keywords

Cesarean sectionpost spinal headacheNear Infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

  • Near Infrared spectroscopy

    Tissue oxygenation

    Up to 20 weeks

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with cesarean section under spinal anesthesia

You may qualify if:

  • Elective cesarean section

You may not qualify if:

  • Not willing to participate in the study
  • Use of anti-psychotic or anti-depressant drugs
  • Patients with headaches

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa University

Tokat Province, 60200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Hakan Tapar

    Gaziosmanpasa University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hakan Tapar

CONTACT

+905056844496hakantapar@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 2, 2019

First Posted

December 5, 2019

Study Start

March 15, 2019

Primary Completion

December 30, 2019

Study Completion

March 10, 2020

Last Updated

December 5, 2019

Record last verified: 2019-12

Locations

TU(1)