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Completed

NCT Number: NCT03536910

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Copeptin

Other

Level of copeptin in maternal blood and umbilical cord blood

Other names: Fetal distress

Primary outcomes

  1. Changes in copeptin levels after general or spinal anesthesia

    Time frame: Baseline and immediately after surgery from maternal blood and arterial and venous umbilical cord at birth

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Evaluation of Copeptin Levels in Elective Cesarean Section With Spinal and General Anesthesia and Their Relationship With Fetal Stress: Prospective Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 25, 2018
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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