ANZCTR - Registration

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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]

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

Fetal oxidative stress of newborn

Condition category

Condition code

Anaesthesiology

Anaesthetics

Reproductive Health and Childbirth

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]

Prevention

Intervention code [2]

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]

Total antioxidant status (TAS) assessed using blood sample from umbilical artery after clamping umbilical cord

Timepoint [1]

At the 0.minute after delivery.

Primary outcome [2]

Total oxidant status (TOS) assessed using blood sample from umbilical artery after clamping umbilical cord

Timepoint [2]

At the 0.minute after delivery.

Primary outcome [3]

Nitric oxide (NO) measurement using blood sample from umbilical artery after clamping umbilical cord

Timepoint [3]

At the 0. minute after delivery

Secondary outcome [1]

Fetal APGAR score

Timepoint [1]

1 and 5 minutes after baby was delivered

Secondary outcome [2]

Fetal birthweight assessed by weight scale

Timepoint [2]

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

Sex

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

15/03/2016

Date of last participant enrolment

Anticipated

Actual

25/07/2016

Date of last data collection

Anticipated

Actual

25/07/2016

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Baskent University

Address [1]

Hocacihan Mah. Saray Cad. No.1 Selcuklu/Konya

Country [1]

Turkey

Primary sponsor type

University

Name

Baskent University

Address

Hocacihan Mah. Saray Cad. No. 1 Selcuklu/KONYA

Country

Turkey

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Baskent University

Ethics committee address [1]

Hocacihan Mah. Saray Cad. No.1 Selcuklu/Konya

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

11/03/2016

Approval date [1]

11/03/2016

Ethics approval number [1]

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

Dr Omer Karaca

Address

Baskent University Konya Medical and Research Center
Hocacihan Mah. Saray Cad. No.1 Selcuklu / Konya

Country

Turkey

Phone

+905301565776

Fax

dromerkaraca@hotmail.com

Contact person for public queries

Name

Omer Karaca

Address

Baskent University Konya Medical and Research Center
Hocacihan Mah. Saray Cad. No.1 Selcuklu / Konya

Country

Turkey

Phone

+905301565776

Fax

dromerkaraca@hotmail.com

Contact person for scientific queries

Name

Omer Karaca

Address

Baskent University Konya Medical and Research Center
Hocacihan Mah. Saray Cad. No.1 Selcuklu / Konya

Country

Turkey

Phone

+905301565776

Fax

dromerkaraca@hotmail.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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