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

Fetal Distress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03536910
• Other study ID #: No protocol ID
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: February 2019
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Insipidus
• Fetal Distress

Intervention

Other:
• Copeptin
Level of copeptin in maternal blood and umbilical cord blood

Locations

Country	Name	City	State
Turkey	Istanbul University Cerrahpasa Medical Faculty	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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