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

NCT ID: NCT03536910

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2018-10-31

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.

Conditions

Fetal Distress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

General anesthesia

Group Type: OTHER

Copeptin

Intervention Type: OTHER

Level of copeptin in maternal blood and umbilical cord blood

Spinal anesthesia

Group Type: OTHER

Copeptin

Intervention Type: OTHER

Level of copeptin in maternal blood and umbilical cord blood

Interventions

Copeptin

Level of copeptin in maternal blood and umbilical cord blood

Intervention Type: OTHER

Other Intervention Names

Fetal distress

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Ece YAMAK ALTINPULLUK

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ece YAMAK ALTINPULLUK, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul University

Locations

Istanbul University Cerrahpasa Medical Faculty

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

No protocol ID

Identifier Type: -

Identifier Source: org_study_id