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Trial registered on ANZCTR


Registration number
ACTRN12615000682549
Ethics application status
Approved
Date submitted
28/05/2015
Date registered
1/07/2015
Date last updated
1/07/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of early breastfeeding on maternal oxidative stress.
Scientific title
Does early breastfeeding in the operating room during cesarean section effect maternal oxidative stress and antioxidant capacity, a randomised controlled study
Secondary ID [1] 286436 0
nil known
Universal Trial Number (UTN)
U1111-1168-7997
Trial acronym
-
Linked study record

Health condition
Health condition(s) or problem(s) studied:
maternal oxidative stress 294606 0
maternal antioxidant capacity 294607 0
postoperative analgesic requirement 294609 0
Condition category
Condition code
Reproductive Health and Childbirth 294908 294908 0 0
Breast feeding
Anaesthesiology 294909 294909 0 0
Other anaesthesiology
Metabolic and Endocrine 294910 294910 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Immediate skin to skin contact during ceserean section, right after the delivery of the baby, will be maintained for ten minutes between the mother and the child. The breastfeeding will be provided in the operating room during this contact.

In the postoperative period, maternal oxidative stress and antioxidant capacity will be measured.

The correlation between maternal oxidative stress and antioxidant capacity will be analysed.
Intervention code [1] 291713 0
Behaviour
Intervention code [2] 292026 0
Prevention
Comparator / control treatment
The control behaviour will be the breastfeeding 1 hour after ceserean section in the ward.
Control group
Active

Outcomes
Primary outcome [1] 294899 0
Mean maternal total oxidant status levels
Serum total oxidant status (TOS) will be measured spectrophotometrically, by TOS assay kit according the manufacturer’s protocol.
Timepoint [1] 294899 0
Baseline and at 15 minutes after ceserean section
Primary outcome [2] 294900 0
Mean maternal total antioxidant capacity levels
Serum total antioxidant capacity (TAS) will be measured spectrophotometrically, by TAS assay kit according the manufacturer’s protocol.
Timepoint [2] 294900 0
Baseline and at 15 minutes after ceserean section
Primary outcome [3] 294901 0
Mean maternal oxytocin levels and the correlation of these levels with total oxidant status and total antioxidant capacity.

Serum oxytocin levels will be measured with oxytocin assay kit according to the manufacturer’s protocol.
Timepoint [3] 294901 0
Baseline and at 15 minutes after ceserean section
Secondary outcome [1] 314310 0
Total analgesic consumption in the postoperative period.

Patient's tramadol consumption after ceserean section will be recorded.
Timepoint [1] 314310 0
Postoperatively for 48 hours.
Secondary outcome [2] 314311 0
Visual analog scoring for postoperative pain
Timepoint [2] 314311 0
48 hours after the operation.

Eligibility
Key inclusion criteria
Healthy pregnant patients, between age 18 and 35, who will have an elective ceserean section with regional (spinal) anesthesia.
Minimum age
18 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The pregnant patients who have any systemic disease, cuagulation abnormalities, preeclampsia, eclampsia, acute or chronic fetal distress, multiple pregnancies or preterm labour.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer based randomisation
The allocation concealment will be provided with sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The number of participants needed is determined by referring to published data of studies similar to our concept . We chose the significance value as 0.05 and beta value 0.20 and the power 0.80. We estimated the difference of interest and the standard deviation based on results from previous studies. Based on these results, we calculated the sample size. We plan to performe statistical analysis using SPSS. We plan to use Student’s t test to evaluate comparisons between groups about demographic, clinical and biochemical values and express the results as the mean and standart deviation or median range.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2015
Actual
1/06/2015
Date of last participant enrolment
Anticipated
1/08/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 6845 0
Turkey
State/province [1] 6845 0

Funding & Sponsors
Funding source category [1] 291488 0
Self funded/Unfunded
Name [1] 291488 0
Beril Yuksel
Country [1] 291488 0
Turkey
Primary sponsor type
Individual
Name
Beril Yuksel
Address
Work Adress:
Dumlupinar University Faculty of Medicine
Okmeydani Street. PO:43050

Kutahya
Country
Turkey
Secondary sponsor category [1] 289838 0
Individual
Name [1] 289838 0
Onur Balaban
Address [1] 289838 0
Work Adress:
Dumlupinar University Faculty of Medicine
Okmeydani Street. PO:43050

Kutahya
Country [1] 289838 0
Turkey
Other collaborator category [1] 278441 0
Individual
Name [1] 278441 0
Ilker Ital
Address [1] 278441 0
Work Adress:
Dumlupinar University Faculty of Medicine
Okmeydani Street. PO:43050

Kutahya
Country [1] 278441 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292927 0
Dumlupinar University Clinical Research Ethics Committee
Ethics committee address [1] 292927 0
Dumlupinar University Faculty of Medicine
Okmeydani Street. PO:43050

Kutahya
Ethics committee country [1] 292927 0
Turkey
Date submitted for ethics approval [1] 292927 0
14/05/2015
Approval date [1] 292927 0
28/05/2015
Ethics approval number [1] 292927 0
2015-86/04

Summary
Brief summary
After birth with cesarean section, mothers and neonates are exposed to oxidative stress. Human milk contains components that protect the infant from infections and the oxidative stress caused during transition from intrauterine to extrauterine life.

Human milk is very well known to have antioxidative properties. Brest-fed children were shown to have higher antioxidative capacity in blood and lower oxidative stress compared to formula-fed infants (Szalagatys 2004, Korchazhkina 2006).

In many hospitals in Turkey, our usual practice during cesarean section is handling the baby to a neonatal team, consisting of pediatricians or a mid-wife, who remove the baby to a radiant warmer right after birth and giving the baby back to mother in the ward, after one or two hours period of observation in the recovery room.

Immediate skin to skin care and early breastfeeding, was shown to promote maternal-neonatal bonding and thermoregulation of the infants (Burke- Aaronson, 2015) as well as reducing the delay of lactation and the likelihood of formula supplementation (Stevens 2014). Implementing immediate skin to skin care is recommended in many latest international reports for the well being of the neonate (Crenshaw 2014, Burke-Aaronson 2015).

Besides the well known positive effects on the infants, the effect of skin to skin contact and early breastfeeding on maternal oxidative stress and antioxidant capacity is not studied before.

In this study, we aim to find whether or not early breastfeeding during cesarean section, prevents the maternal oxidative stress. In addition, we also aim to analyse whether there is any correlation between the maternal oxytocin levels and total antioxidant capacity or total oxidant status.
Our secondary aim in this study is to evaluate the relation between postoperative pain and postoperative oxytocin levels.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56134 0
A/Prof Beril Yuksel
Address 56134 0
Work Adress:
Dumlupinar University Faculty of Medicine
Okmeydani Street. PO:43050

Kutahya
Country 56134 0
Turkey
Phone 56134 0
+90 532 8852652
Fax 56134 0
Email 56134 0
[email protected]
Contact person for public queries
Name 56135 0
A/Prof Beril Yuksel
Address 56135 0
Work Adress:
Dumlupinar University Faculty of Medicine
Okmeydani Street. PO:43050

Kutahya
Country 56135 0
Turkey
Phone 56135 0
+90 532 8852652
Fax 56135 0
Email 56135 0
[email protected]
Contact person for scientific queries
Name 56136 0
A/Prof Beril Yuksel
Address 56136 0
Work Adress:
Dumlupinar University Faculty of Medicine
Okmeydani Street. PO:43050

Kutahya
Country 56136 0
Turkey
Phone 56136 0
+90 532 8852652
Fax 56136 0
Email 56136 0
[email protected]

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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