ANZCTR - Registration

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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]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

breastfeeding

Condition category

Condition code

Reproductive Health and Childbirth

Breast feeding

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

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]

Rate of breastfeeding in the first 24 hours after surgery assessed through medical records

Timepoint [1]

24 hours post surgery

Primary outcome [2]

Rate of breastfeeding in the first hour after surgery through medical records

Timepoint [2]

First hour post surgery

Secondary outcome [1]

Rate of breastfeeding in the first 6 months after birth assessed through medical records

Timepoint [1]

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?

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]

Turkey

State/province [1]

Bursa

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Derya Karasu

Address [1]

Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/ Bursa

Country [1]

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]

Individual

Name [1]

Canan Yilmaz

Address [1]

Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/ Bursa

Country [1]

Turkey

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Yuksek Ihtisas Training and Education Hospital Clinical Research Ethics Committee

Ethics committee address [1]

Bursa Yuksek Ihtisas Training and Education Hospital 
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/ Bursa
Turkey

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

29/05/2015

Approval date [1]

03/06/2015

Ethics approval number [1]

2015/11-09

Summary

Brief summary

Purpose: We aim to compare the effects of general anaesthesia and spinal anaesthesia on breastfeeding in caesarean section cases.
Method: Pregnant subjects at term who were admitted for caesarean section and whom we could contact via phone were included. 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. The subjects’ demographic data were recorded. The subjects were divided into two groups: those undergoing general anaesthesia (Group G) and those undergoing spinal anaesthesia (Group S). Breastfeeding was assessed by another anaesthetist at post-operative 1 and 24 hours and 6 months. 
Findings: A total of 248 subjects were assessed statistically. No statistically significant difference was found between the two groups in terms of first breastfeeding interval. The rate of breastfeeding within 1 hour of delivery was 15.5% in Group G and 21.8% in Group S. The difference was not statistically significant. No statistically significant difference was found between the groups in terms of the rate of breastfeeding within the first 24 hours, either. The rate of breastfeeding in the 6-month period was statistically significantly higher in Group S than Group G.
Result: We believe that our study contributes to the literature on investigating spinal anaesthesia and general anaesthesia in breastfeeding subjects. We think that in term pregnancies, the type of anaesthesia does not affect the first breastfeeding interval; however, spinal anaesthesia is superior to general anaesthesia in long-term breastfeeding.

Trial website

Trial related presentations / publications

no applicable

Public notes

Contacts

Principal investigator

Name

Dr 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

Phone

+905057281175

Fax

drderyatopuz@gmail.com

Contact person for public queries

Name

Canan Yilmaz

Address

Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/ Bursa

Country

Turkey

Phone

+90 5059045989

Fax

dr_cnnylmz@yahoo.com

Contact person for scientific queries

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

Phone

+905057281175

Fax

drderyatopuz@gmail.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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Documents added automatically

No additional documents have been identified.

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