Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03536910
Recruitment Status : Completed
First Posted : May 25, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Ece YAMAK ALTINPULLUK, Istanbul University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Fetal Distress Other: Copeptin Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Evaluation of Copeptin Levels in Elective Cesarean Section With Spinal and General Anesthesia and Their Relationship With Fetal Stress: Prospective Study
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
General anesthesia Other: Copeptin
Level of copeptin in maternal blood and umbilical cord blood
Other Name: Fetal distress
Spinal anesthesia Other: Copeptin
Level of copeptin in maternal blood and umbilical cord blood
Other Name: Fetal distress


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnancy
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536910


Locations
Layout table for location information
Turkey
Istanbul University Cerrahpasa Medical Faculty
Istanbul, Turkey, 34098
Sponsors and Collaborators
Istanbul University
Investigators
Layout table for investigator information
Principal Investigator: Ece YAMAK ALTINPULLUK, MD Istanbul University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ece YAMAK ALTINPULLUK, Principal Investigator, Istanbul University
ClinicalTrials.gov Identifier: NCT03536910    
Other Study ID Numbers: No protocol ID
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ece YAMAK ALTINPULLUK, Istanbul University:
copeptin levels
Cesarean section
general anesthesia
spinal anesthesia
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Insipidus
Fetal Distress
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Arginine Vasopressin
 Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs