Evaluation of Copeptin Levels in Elective Cesarean Section With Different Anesthetic Technique

Not Applicable

Completed

• Conditions: Fetal Distress

• Registration Number: NCT03536910
• Lead Sponsor: Istanbul University

Brief Summary

In this study, investigators aimed to investigate the effects of general and spinal anesthesia techniques on copeptin levels during cesarean section and their relation with fetal distress.

Detailed Description

During the delivery process, the mother and the baby generate some endocrine responses to this emotional and physical stressful action. Arginin-Vasopressin prohormone (copeptin), which is more stable and measurable in blood, is used as an endogenous stress indicator. Copeptin levels have been shown to be significantly increased in vaginally delivery when compared to cesarean section (c / s). In a caesarean section; it is a known fact that when the general anesthetic method and the used anesthetic substances are taken into consideration, it gives a significant stress to the mother and the baby. Spinal anesthesia with no impaired fetal oxygenation and without orotracheal intubation and neuromuscular blockers may reduce fetal distress. However, there was no study investigating the effect of the anesthesia techniques in elective cesarean section on the fetal stress and the level of copeptin, in the literature review. Therefore investigators aimed to compare spinal and general anesthesia technique in elective cesarean section, to evaluate level of copeptin and their relation with fetal distress.Investigators hope that this study will guide the anesthesia method that can be chosen primarily in caesarean section.

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-05-24
• Study First Posted: 2018-05-25
• Primary Completion: 2018-07-31
• Study Completion: 2018-10-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• 18-40 years of age
• ASA I-II
• 36-40 gestational weeks
• BMI ≤ 40
• Undergoing elective cesarean section

Exclusion Criteria

• Coagulopathy
• Known central or peripheral nerve disease
• fetal anomalies
• birth weight less than 2000 grams and above 4500 grams,
• infants with a risk of meconium or amniotic fluid aspiration
• kidney failure, diabetes mellitus, hypertension, cardiac disease, antepartum hemorrhage, asthma bronchiole, Rh incompatibility, congenital malformations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in copeptin levels after general or spinal anesthesia	Baseline and immediately after surgery from maternal blood and arterial and venous umbilical cord at birth

Trial Locations

Locations (1)

Istanbul University Cerrahpasa Medical Faculty; 🇹🇷 Istanbul, Turkey