NCT03594695

Brief Summary

The stress response to surgery is a result of tissue injury with local and systemic inflammation that contributes to the postoperative outcome. Anesthesia is known to effect perioperative stress response Regional anesthesia modifies stress response through afferent blockage whereas general anesthesia affects the stress response via central modulation. High sensitive C-reactive protein and neutrophil to lymphocyte ratio are used for evaluation of inflammation. The aim of this study was to document the value hs-CRP and NLR in perioperative stress response in two different anesthesia methods applied to term pregnant women undergoing elective ceserean section (C/S).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

July 20, 2018

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2018

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2018

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

26 days

First QC Date

January 15, 2018

Last Update Submit

October 12, 2018

Conditions

Cesarean Delivery Affecting NewbornAnesthesiaInflammatory Response

Keywords

cesarean section, anesthesia, hs-CRP, NLR

Outcome Measures

Primary Outcomes (2)

  • Evaluation of the change in HSCRP levels

    Measurement of high sensitive C reactive protein levels in different time points in order to evaluate the change in HSCRP levels

    preoperative, postoperative 2nd and 4th hours, fetal cord blood sample (following delivery)

  • Evaluation of the change in NLR

    Measurement of the Neutrophil to Lymphocyte Ratio in different time points in order to evaluate the change in the Neutrophil to Lymphocyte Ratios

    preoperative, postoperative 2nd and 4th hours, fetal cord blood sample (following delivery)

Study Arms (2)

Group G

Patients undergoing general anesthesia HSCRP and NLR measurement

Diagnostic Test: HSCRP and NLR

Group R

Patients undergoing spinal anesthesia HSCRP and NLR measurement

Diagnostic Test: HSCRP and NLR

Interventions

HSCRP and NLRDIAGNOSTIC_TEST

hs-CRP levels and NLR values will be studied from routine blood samples.

Group GGroup R

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis observational study is conducted in cesarean sections
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population is composed of healthy pregnant women without chronic diseases at term (36-41 weeks of pregnancy).

You may qualify if:

  • Healthy pregnant women without chronic diseases at term (36-41 weeks of pregnancy)

You may not qualify if:

  • refusal to participate,
  • chronic diseases (diabetes mellitus, hypertension, heart disease, renal disease, hypo/hyperthyroidism)
  • any infections,
  • smoking
  • contraindications for central neuraxial anesthesia.
  • Pregnancies complicated with rupture of membranes, placenta previa, eclampsia/preeclampsia, and abruptio placenta
  • fetal anomalies,
  • abnormality detected at fetal well-being tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ufuk University

Ankara, Balgat, 06520, Turkey (Türkiye)

Location

Related Publications (2)

  • Chen Y, Jiang S, Wu Y. Effect of 2 different anesthesia methods on stress response in neurosurgical patients with hypertension or normal: A prospective clinical trial. Medicine (Baltimore). 2016 Aug;95(35):e4769. doi: 10.1097/MD.0000000000004769.

    PMID: 27583931BACKGROUND

  • Farzadnia M, Ayatollahi H, Hasan-Zade M, Rahimi HR. A comparative study of vascular cell adhesion molecule-1 and high-sensitive C-reactive protein in normal and preeclamptic pregnancies. Interv Med Appl Sci. 2013 Mar;5(1):26-30. doi: 10.1556/IMAS.5.2013.1.5. Epub 2013 Mar 19.

    PMID: 24265885BACKGROUND

Study Officials

  • Hakan Yılmaz, MD

    Ufuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

January 15, 2018

First Posted

July 20, 2018

Study Start

July 20, 2018

Primary Completion

August 15, 2018

Study Completion

August 20, 2018

Last Updated

October 15, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)