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Trial registered on ANZCTR


Registration number
ACTRN12616001547437
Ethics application status
Approved
Date submitted
21/05/2016
Date registered
9/11/2016
Date last updated
9/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Regional Anesthesia Type on Fetal Well-being During Cesarean Section

Scientific title
The Effect of Epidural Anesthesia and Spinal Anesthesia on Fetal Oxidative Stress During Cesarean Section
Secondary ID [1] 289165 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Regional anesthesia type during cesarean section 298695 0
Fetal oxidative stress of newborn 300347 0
Condition category
Condition code
Anaesthesiology 300218 300218 0 0
Anaesthetics
Reproductive Health and Childbirth 300219 300219 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Epidural anesthesia (18G Touhy needle, 20G epidural catheter,12 mL of total 20 mL solution prepared with 15 mL 0.5%w/v bupivacaine and 2 mL(100 micrograms) phentanyl)
Operation will be started after anesthesia level reaches T6
All of the procedure will be applied by an anaesthesiologist in operation room
Intervention code [1] 294691 0
Prevention
Intervention code [2] 295950 0
Treatment: Drugs
Comparator / control treatment
Spinal anesthesia (L3-4 or L4-5 interspace, 2.5 mL 0.5%w/v heavy marcaine)
All of the procedure will be applied by an anaesthesiologist in operation room
Control group
Active

Outcomes
Primary outcome [1] 298233 0
Total antioxidant status (TAS) assessed using blood sample from umbilical artery after clamping umbilical cord
Timepoint [1] 298233 0
At the 0.minute after delivery.
Primary outcome [2] 299698 0
Total oxidant status (TOS) assessed using blood sample from umbilical artery after clamping umbilical cord
Timepoint [2] 299698 0
At the 0.minute after delivery.
Primary outcome [3] 299699 0
Nitric oxide (NO) measurement using blood sample from umbilical artery after clamping umbilical cord
Timepoint [3] 299699 0
At the 0. minute after delivery
Secondary outcome [1] 323645 0
Fetal APGAR score
Timepoint [1] 323645 0
1 and 5 minutes after baby was delivered
Secondary outcome [2] 327885 0
Fetal birthweight assessed by weight scale
Timepoint [2] 327885 0
5 minutes after baby was delivered

Eligibility
Key inclusion criteria
term pregnancy (37-40 weeks)
normal pregnancy
between 18 and 40 years
non smokers
non diabetes mellitus and hypertension
Minimum age
18 Years
Maximum age
40 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
emergency cesarean section, those who used drugs except iron supplements and those who smoked during pregnancy, those with complications of pregnancy, those who were diagnosed with intrauterine growth retardation and fetal malformation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7868 0
Turkey
State/province [1] 7868 0

Funding & Sponsors
Funding source category [1] 293561 0
University
Name [1] 293561 0
Baskent University
Address [1] 293561 0
Hocacihan Mah. Saray Cad. No.1 Selcuklu/Konya
Country [1] 293561 0
Turkey
Primary sponsor type
University
Name
Baskent University
Address
Hocacihan Mah. Saray Cad. No. 1 Selcuklu/KONYA
Country
Turkey
Secondary sponsor category [1] 292380 0
None
Name [1] 292380 0
Address [1] 292380 0
Country [1] 292380 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295039 0
Baskent University
Ethics committee address [1] 295039 0
Hocacihan Mah. Saray Cad. No.1 Selcuklu/Konya
Ethics committee country [1] 295039 0
Turkey
Date submitted for ethics approval [1] 295039 0
11/03/2016
Approval date [1] 295039 0
11/03/2016
Ethics approval number [1] 295039 0
94603339-604.01.02/10084

Summary
Brief summary
In cesarean section operations for determination of anesthesia method besides the patient’s and the doctor’s preference, fetal condition is also important. Oxidative and antioxidative defense systems of body are in a balance normally. Situations in which an imbalance in favor of oxidative damage occurs are associated with serious disorders in newborn. Spinal anesthesia is the most widely used regional anesthesia method for cesarean section, leading to both increased sensitivity of newborn to oxidative stress and also increased maternal free oxygen radicals, and is the method which leads to uteroplacental hypoperfusion by causing hypotension and bradycardia and to increased ephedrine need. During epidural anesthesia complications like hypotension are less encountered and are less serious
The aim of our study is the comparison of the effect of spinal anesthesia on newborn fetal oxidative stress during elective cesarean section of parturients with normal pregnancy versus the effect of epidural anesthesia. For this aim Total Antioxidative Status (TAS), Total Oxidative Status (TOS), nitric oxide (NO) level obtained from blood sample taken from umbilical artery after clamping umbilical cord, arterial blood gas will be analysed.and 1st and 5th minute APGAR scores of the newborn will be assessed by a newborn pediatrician blind to the anesthesia type.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65346 0
Dr Omer Karaca
Address 65346 0
Baskent University Konya Medical and Research Center
Hocacihan Mah. Saray Cad. No.1 Selcuklu / Konya
Country 65346 0
Turkey
Phone 65346 0
+905301565776
Fax 65346 0
Email 65346 0
dromerkaraca@hotmail.com
Contact person for public queries
Name 65347 0
Dr Omer Karaca
Address 65347 0
Baskent University Konya Medical and Research Center
Hocacihan Mah. Saray Cad. No.1 Selcuklu / Konya
Country 65347 0
Turkey
Phone 65347 0
+905301565776
Fax 65347 0
Email 65347 0
dromerkaraca@hotmail.com
Contact person for scientific queries
Name 65348 0
Dr Omer Karaca
Address 65348 0
Baskent University Konya Medical and Research Center
Hocacihan Mah. Saray Cad. No.1 Selcuklu / Konya
Country 65348 0
Turkey
Phone 65348 0
+905301565776
Fax 65348 0
Email 65348 0
dromerkaraca@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary