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

February 25, 2019 updated by: Ece YAMAK ALTINPULLUK, Istanbul University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34098
        • Istanbul University Cerrahpasa Medical Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: General anesthesia
Other: Copeptin
Level of copeptin in maternal blood and umbilical cord blood
Other Names:
  • Fetal distress
Other: Spinal anesthesia
Other: Copeptin
Level of copeptin in maternal blood and umbilical cord blood
Other Names:
  • Fetal distress

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline and immediately after surgery from maternal blood and arterial and venous umbilical cord at birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Principal Investigator: Ece YAMAK ALTINPULLUK, MD, Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Actual)

July 31, 2018

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

May 24, 2018

First Posted (Actual)

May 25, 2018

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No protocol ID

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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