Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000677404
Ethics application status
Approved
Date submitted
31/03/2016
Date registered
25/05/2016
Date last updated
30/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of the effects of general and spinal anaesthesia during cesearean section on breastfeeding
Scientific title
A comparison of the effects of general and spinal anaesthesia during cesearean section on breastfeeding
Secondary ID [1] 288870 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breastfeeding 298162 0
Condition category
Condition code
Reproductive Health and Childbirth 298328 298328 0 0
Breast feeding
Anaesthesiology 298933 298933 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
6
Target follow-up type
Months
Description of intervention(s) / exposure
The patients’ demographic data were recorded. The patients were divided into two groups based on the type of anaesthesia they received during their caesarean section. Patients were enrolled into the study post-delivery.
Non randomized.
Group G (General anaesthesia): Preoxygenation was achieved with 100% oxygen for 3 minutes. For induction of general anaesthesia, intravenous 2 mg/kg propofol (Propofol (R), Fresenius-kabi; Istanbul, Turkey), intravenous 1.5 mg/kg, lidocaine (Jetmonal(R) 2%, Adeka; Istanbul, Turkey) and intravenous 0.9 mg/kg rocuronium (Esmeron(R), MSD; Istanbul, Turkey) were administered. After the infant was delivered, intravenous 1 mcg/kg fentanyl (Talinat(R), Vem; Istanbul, Turkey) was administered. For maintenance, 50% O2+ 50% air + 1 MAC sevoflurane (Sevorane(R), Abbvie; Istanbul, Turkey) was administered. Tenoxicam (Tilcotil(R), Deva; Istanbul, Turkey) 20 mg was administered intravenously for postoperative pain.
Group S (Spinal anaesthesia): Spinal anaesthesia was performed by inserting a 25G Quince needle at the L3-4 or L4-5 space. Intratekal 12 mg hyperbaric bupivacaine (Bustesin %0.5 spinal heavy (R), Vem; Istanbul, Turkey) was administered.
The patients were assessed by another anaesthetist at postoperative 1 and 24 hours and 6 months.
Intervention code [1] 294705 0
Not applicable
Comparator / control treatment
Group S (spinal anaesthesia): While the patients were in sitting position, appropriate site cleaning was performed with the 25G Quincke spinal needle through the L3-L4 or L4-L5 disc space. 15mg 0.5% bupivacaine (Bustesin %0.5 spinal heavy(R), Vem; Istanbul, Turkey) was administered into subarachnoid space.
Control group
Active

Outcomes
Primary outcome [1] 297819 0
Rate of breastfeeding in the first 24 hours after surgery assessed through medical records
Timepoint [1] 297819 0
24 hours post surgery
Primary outcome [2] 298173 0
Rate of breastfeeding in the first hour after surgery through medical records
Timepoint [2] 298173 0
First hour post surgery
Secondary outcome [1] 322344 0
Rate of breastfeeding in the first 6 months after birth assessed through medical records
Timepoint [1] 322344 0
6 months post surgery

Eligibility
Key inclusion criteria
Pregnant subjects at term who were admitted for caesarean section and whom we could contact via phone were included
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-term subjects, those with foetal distress, mentally retarded subjects, those who did not cooperate and those who do not speak Turkish were excluded from the study. The subjects whose infants were admitted to the neonatal intensive care unit after delivery were also excluded.

Study design
Purpose
Duration
Selection
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/06/2015
Date of last participant enrolment
Anticipated
Actual
30/09/2015
Date of last data collection
Anticipated
Actual
1/04/2016
Sample size
Target
330
Accrual to date
Final
248
Recruitment outside Australia
Country [1] 7761 0
Turkey
State/province [1] 7761 0
Bursa

Funding & Sponsors
Funding source category [1] 293234 0
Self funded/Unfunded
Name [1] 293234 0
Derya Karasu
Country [1] 293234 0
Turkey
Primary sponsor type
Individual
Name
Derya Karasu
Address
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/ Bursa
Country
Turkey
Secondary sponsor category [1] 292033 0
Individual
Name [1] 292033 0
Canan Yilmaz
Address [1] 292033 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/ Bursa
Country [1] 292033 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294714 0
Yuksek Ihtisas Training and Education Hospital Clinical Research Ethics Committee
Ethics committee address [1] 294714 0
Ethics committee country [1] 294714 0
Turkey
Date submitted for ethics approval [1] 294714 0
29/05/2015
Approval date [1] 294714 0
03/06/2015
Ethics approval number [1] 294714 0
2015/11-09

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64722 0
Dr Derya Karasu
Address 64722 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/ Bursa
Country 64722 0
Turkey
Phone 64722 0
+905057281175
Fax 64722 0
Email 64722 0
[email protected]
Contact person for public queries
Name 64723 0
Canan Yilmaz
Address 64723 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/ Bursa
Country 64723 0
Turkey
Phone 64723 0
+90 5059045989
Fax 64723 0
Email 64723 0
[email protected]
Contact person for scientific queries
Name 64724 0
Derya Karasu
Address 64724 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/ Bursa
Country 64724 0
Turkey
Phone 64724 0
+905057281175
Fax 64724 0
Email 64724 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.