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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03536910
Other study ID # No protocol ID
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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