NCT05409885

Brief Summary

The aim of the study was to evaluate the effects of anesthetic techniques (general and spinal anesthesia) on umbilical cord neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR) and mean platelet volume (MPV) in patients undergoing cesarean section.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 20, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2022

Completed
Last Updated

July 21, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

April 20, 2022

Last Update Submit

July 20, 2022

Conditions

Keywords

anesthesiacesarean sectionneutrophil-to-lymphocyte ratioplatelet-to-lymphocyte ratiomean platelet volume

Outcome Measures

Primary Outcomes (1)

  • neutrophil-to-lymphocyte ratio

    Evaluate the effects of NLR in patients undergoing cesarean section

    within 5 minute, following delivery

Secondary Outcomes (4)

  • platelet-to-lymphocyte ratio

    within 5 minute, following delivery

  • mean platelet volume

    within 5 minute, following delivery

  • Newborn Apgar score 1st minute

    1st minute after birth

  • Newborn Apgar score 5th minute

    5th minute after birth

Study Arms (2)

General anesthesia group

Evaluate the effects of general anesthesia on NLR, PLR and MPV in patients undergoing cesarean section.

Other: General anesthesia

Spinal anesthesia group

Evaluate the effects of spinal anesthesia on NLR, PLR and MPV in patients undergoing cesarean section.

Other: Spinal anesthesia

Interventions

Evaluate the effects of general anesthesia on NLR, PLR and MPV in patients undergoing cesarean section.

General anesthesia group

Evaluate the effects of spinal anesthesia on NLR, PLR and MPV in patients undergoing cesarean section.

Spinal anesthesia group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

elective ceserean surgery

You may qualify if:

  • years
  • American Society of Anesthesiology (ASA) II-III
  • elective ceserean surgery

You may not qualify if:

  • declining to give written informed consent
  • under 18 years of age or over 45 years of age
  • factors affecting NLR, PLR and MPV such as preeclampsia, HELLP syndrome or premature rupture of membranes
  • history of neurological and/or neuromucular disease
  • cooperation cannot be established
  • emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Antalya, 07100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Anesthesia, GeneralAnesthesia, Spinal

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaAnesthesia, Conduction

Study Officials

  • Kerem İnanoğlu

    Antalya TRH

    PRINCIPAL INVESTIGATOR
  • Esra Bağ

    Antalya TRH

    PRINCIPAL INVESTIGATOR
  • Arzu Karaveli

    Antalya TRH

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2022

First Posted

June 8, 2022

Study Start

March 20, 2022

Primary Completion

July 1, 2022

Study Completion

July 7, 2022

Last Updated

July 21, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations