Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000614291
Ethics application status
Approved
Date submitted
20/07/2009
Date registered
22/07/2009
Date last updated
12/03/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Epidural Pethidine after Caesarean Section. A pilot study of initiation of lactation, plasma and milk levels of pethidine and norpethidine and the behaviour of breast-fed infants.
Scientific title
In women undergoing caesarean section with post-operative patient controlled epidural analgesia (PCEA) with pethidine and their infants, is the initiation and establishment of lactation and breastfeeding behaviour comparable to those who have not received pethidine PCEA after caesarean section and to those who had vaginal delivery.
Secondary ID [1] 281265 0
1526/EW
Universal Trial Number (UTN)
Trial acronym
The EPACS Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Initiation and establishment of lactation after caesarean and vaginal delivery 237196 0
Breastfeeding behaviour in the infant 237197 0
Condition category
Condition code
Reproductive Health and Childbirth 237519 237519 0 0
Breast feeding
Anaesthesiology 239653 239653 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Intervention group: Women (and their infants) having elective caesarean section using pethidine 20 mg at 15 minute lockout time via patient controlled epidural boluses
Intervention code [1] 236901 0
Not applicable
Comparator / control treatment
Comparison groups: Women (and their infants) having elective caesarean section not using pethidine PCEA postoperatively and women (and their infants) delivered vaginally who were not exposed to systemic or epidural pethidine.
Control group
Active

Outcomes
Primary outcome [1] 238328 0
Initiation and establishment of lactation: determined by measuring the change in concentration of lactose, sodium, total protein and citrate in small samples of colostrum and breast milk
Timepoint [1] 238328 0
Day 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, and 10 days postpartum
Primary outcome [2] 238329 0
24 hour milk production: measured by the test weighing method
Timepoint [2] 238329 0
Weighing at the end of day 5 and again on day 10
Primary outcome [3] 238330 0
Breast feeding behaviour: assessed by ultrasound and intraoral pressure
Timepoint [3] 238330 0
On Day 2 and Day 10 postpartum
Secondary outcome [1] 244731 0
Plasma concentrations of pethidine and norpethidine
Timepoint [1] 244731 0
At and 6 hours after cessation of pethidine PCEA postoperatively or at 48 hours if still using pethidine PCEA
Secondary outcome [2] 244732 0
Milk concentrations of pethidine and norpethidine
Timepoint [2] 244732 0
At and 6 hours after cessation of pethidine PCEA postoperatively or at 48 hours if still using pethidine PCEA
Secondary outcome [3] 244733 0
Plasma concentrations of pethidine and norpethidine postoperatively among breast-fed infants exposed to maternal pethidine
Timepoint [3] 244733 0
At 48 hours postoperatively
Secondary outcome [4] 244734 0
Neurobehavioural scores (neonatal adaptive capcity score or NACS) and evaluation of breast-feeding behaviour with LATCH-R scores (Latch, Audible swallow, Type of nipple, Comfort and nipple state, Hold: mothers ability to position, and Responsiveness and confidence)
Timepoint [4] 244734 0
Assessed on Day 2 and Day 10 postpartum

Eligibility
Key inclusion criteria
For all:
American Society of Anesthesiologists (ASA) Classification I and II
18 years and over
For study group:
Mothers (and their infants) delivered via elective caesarean at term (37 weeks gestation or more) and preference for pethidine PCEA postoperatively
For comparison groups:
Mothers (and their infants) delivered via elective caesarean not using pethidine PCEA postoperatively
Mothers (and their infants) delivered vaginally who were not exposed to systemic or epidural pethidine during labour
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-elective caesarean delivery
Preoperative opioid use
Multiple pregnancies
Maternal diabetes or impairment of glucose regulation
Abnormal renal function or severe pre-eclampsia
Intolerance or allergy to pethidine
Change to alternative analgesia to pethidine within 24 hours postoperatively
Inability to provide adequate breast milk samples
Neonates requiring admission to intensive care

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/07/2008
Actual
10/08/2008
Date of last participant enrolment
Anticipated
Actual
12/04/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237302 0
Charities/Societies/Foundations
Name [1] 237302 0
Women and Infants Research Foundation
Country [1] 237302 0
Australia
Primary sponsor type
Individual
Name
Dr Yasir Al-Tamimi
Address
c/o Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 236879 0
None
Name [1] 236879 0
Address [1] 236879 0
Country [1] 236879 0
Other collaborator category [1] 788 0
Individual
Name [1] 788 0
Michael Paech
Address [1] 788 0
c/o Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco WA 6008
Country [1] 788 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239399 0
King Edward Memorial Hospital for Women Ethics Committee
Ethics committee address [1] 239399 0
King Edward Memorial Hospital for Women
GPO Box D184
Perth WA 6840
Ethics committee country [1] 239399 0
Australia
Date submitted for ethics approval [1] 239399 0
Approval date [1] 239399 0
03/06/2008
Ethics approval number [1] 239399 0
1526/EW

Summary
Brief summary
This study investigates possible effects of epidural pethidine and norpethidine on the initiation and establishment of lactation and brestfeeding behaviour of the infant.
Trial website
Trial related presentations / publications
Al-Tamimi Y, Ilett KF, Paech MJ, O’Halloran SJ, Hartmann PE. Estimation of
infant dose and exposure to pethidine and norpethidine via breast milk following patient-controlled epidural pethidine for analgesia post caesarean delivery. Int J Obstet Anesth 2011;20:128-134

Sakalidis VS, Williams TM, Hepworth AR, Garbin CP, Hartmann PE, Paech MJ, Al-Tamimi Y, Geddes DT. A comparison of early sucking dynamics during breastfeeding after cesarean section and vaginal birth. Breastfeed Med 2013;8:79-85

Sakalidis VS, Williams TM, Garbin CP, Hepworth AR, Hartmann PE, Paech MJ, Geddes DT. Ultrasound imaging of infant sucking dynamics during the establishment of lactation. J Hum Lact 2013;29:205-13
Public notes

Contacts
Principal investigator
Name 29871 0
Dr Yasir Al-Tamimi
Address 29871 0
Department of Anaesthesia and Pain Medicine, Joondalup Health Campus, Shenton Ave., Joondalup, 6027 WA, Australia
Country 29871 0
Australia
Phone 29871 0
+61 8 94009400
Fax 29871 0
Email 29871 0
[email protected]
Contact person for public queries
Name 13118 0
Michael Paech
Address 13118 0
Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco WA 6008
Country 13118 0
Australia
Phone 13118 0
+61 8 93402222
Fax 13118 0
+61 8 9340 2260
Email 13118 0
[email protected]
Contact person for scientific queries
Name 4046 0
Michael Paech
Address 4046 0
Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road
Subiaco WA 6008
Country 4046 0
Australia
Phone 4046 0
+61 8 93402222
Fax 4046 0
+61 8 9340 2260
Email 4046 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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