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

Primary Purpose

Fetal Distress

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Copeptin

About this trial

This is an interventional other trial for Fetal Distress focused on measuring copeptin levels, Cesarean section, general anesthesia, spinal anesthesia

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Istanbul University Cerrahpasa Medical Faculty

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

General anesthesia

Spinal anesthesia

Arm Description

Outcomes

Primary Outcome Measures

Changes in copeptin levels after general or spinal anesthesia

Secondary Outcome Measures

Full Information

NCT ID

NCT03536910

First Posted

May 15, 2018

Last Updated

February 25, 2019

Sponsor

Istanbul University

1. Study Identification

Unique Protocol Identification Number

NCT03536910

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

May 1, 2018 (Actual)

Primary Completion Date

July 31, 2018 (Actual)

Study Completion Date

October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fetal Distress

Keywords

copeptin levels, Cesarean section, general anesthesia, spinal anesthesia

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

General anesthesia

Arm Type

Other

Arm Title

Spinal anesthesia

Arm Type

Other

Intervention Type

Other

Intervention Name(s)

Copeptin

Other Intervention Name(s)

Fetal distress

Intervention Description

Level of copeptin in maternal blood and umbilical cord blood

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Pregnancy

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ece YAMAK ALTINPULLUK, MD

Organizational Affiliation

Istanbul University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Istanbul University Cerrahpasa Medical Faculty

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

12. IPD Sharing Statement

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

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