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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12616001547437 |
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Date of registration:
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09/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of Regional Anesthesia Type on Fetal Well-being During Cesarean Section
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Scientific title:
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The Effect of Epidural Anesthesia and Spinal Anesthesia on Fetal Oxidative Stress During Cesarean Section
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Date of first enrolment:
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15/03/2016 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12616001547437.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial;
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Phase:
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Dr Omer Karaca
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Address:
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Baskent University Konya Medical and Research Center
Hocacihan Mah. Saray Cad. No.1 Selcuklu / Konya
Turkey |
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Telephone:
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+905301565776 |
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Email:
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dromerkaraca@hotmail.com |
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Affiliation:
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Name:
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Dr Omer Karaca
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Address:
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Baskent University Konya Medical and Research Center
Hocacihan Mah. Saray Cad. No.1 Selcuklu / Konya
Turkey |
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Telephone:
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+905301565776 |
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Email:
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dromerkaraca@hotmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: term pregnancy (37-40 weeks)
normal pregnancy
between 18 and 40 years
non smokers
non diabetes mellitus and hypertension
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
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Females
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Health Condition(s) or Problem(s) studied
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Reproductive Health and Childbirth - Childbirth and postnatal care
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Regional anesthesia type during cesarean section;Fetal oxidative stress of newborn;
Regional anesthesia type during cesarean section
Fetal oxidative stress of newborn
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Anaesthesiology - Anaesthetics
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Intervention(s)
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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
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Primary Outcome(s)
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Nitric oxide (NO) measurement using blood sample from umbilical artery after clamping umbilical cord[At the 0. minute after delivery]
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Total antioxidant status (TAS) assessed using blood sample from umbilical artery after clamping umbilical cord[At the 0.minute after delivery.]
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Total oxidant status (TOS) assessed using blood sample from umbilical artery after clamping umbilical cord[At the 0.minute after delivery.]
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Secondary Outcome(s)
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Fetal APGAR score[1 and 5 minutes after baby was delivered
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Fetal birthweight assessed by weight scale[5 minutes after baby was delivered]
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Source(s) of Monetary Support
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Baskent University
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Ethics review
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Status: Approved
Approval date:
Contact:
Baskent University
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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