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Trial registered on ANZCTR


Registration number
ACTRN12618001012268
Ethics application status
Approved
Date submitted
23/05/2018
Date registered
18/06/2018
Date last updated
18/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of maternal and fetal fentanyl concentration following fentanyl use in childbirth
Scientific title
Fentanyl concentration in maternal and umbilical cord plasma following intranasal or subcutaneous administration in labour
Secondary ID [1] 294985 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childbirth 307995 0
Condition category
Condition code
Reproductive Health and Childbirth 307026 307026 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of this study is to compare the concentration of fentanyl between maternal and cord blood in women administered intranasal (IN) or subcutaneous (SC) fentanyl for labour analgesia. Corresponding 3mL maternal and 1-3mL umbilical cord blood samples will be collected from women administered intrapartum fentanyl and their neonates. Duration of observation includes the time from first fentanyl dose administered in labour to 30 minutes post birth.
Intervention code [1] 301314 0
Not applicable
Comparator / control treatment
Samples will be collected at the time of birth (where possible within 30 minutes of birth) and not at a predetermined time following maternal dosing. As such, plasma concentration ratios are used as an indicator of fetal exposure to the drug relative to the mother.
Control group
Active

Outcomes
Primary outcome [1] 306007 0
Plasma concentration of fentanyl to assess the relative exposure of the neonate to the maternal administration.
Timepoint [1] 306007 0
At time of birth
Secondary outcome [1] 347289 0
nil
Timepoint [1] 347289 0
n/a

Eligibility
Key inclusion criteria
Age: 18- 40 years
Have no known allergy to fentanyl
Women who have received either intranasal or subcutaneous fentanyl in labour
Viable fetus in a vertex presentation
Vaginal birth at term (37-42 weeks)
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pre-term birth
Multiple birth
Operative birth
Have a known allergy to fentanyl

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Data will be collected and entered electronically into SPSS version 21. Nominal data will be analysed using chi-square and ordinal data using Mann-Whitney U test. Descriptive statistics will be used to report frequencies, means and standard deviations or median and interquartile range. Data comparing maternal and cord plasma concentration ratios will be compared using two-tailed paired and unpaired t-tests or Mann-Whitney U tests where appropriate. These results will be presented as mean difference and 95% confidence interval. Statistical significance will be set at p<0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/03/2017
Date of last participant enrolment
Anticipated
30/06/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
33
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 10977 0
Gawler Health Service - Gawler East
Recruitment postcode(s) [1] 22766 0
5118 - Gawler East

Funding & Sponsors
Funding source category [1] 299571 0
University
Name [1] 299571 0
The University of South Australia
Country [1] 299571 0
Australia
Primary sponsor type
University
Name
The University of South Australia
Address
108 North Terrace, Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 298882 0
None
Name [1] 298882 0
not applicable
Address [1] 298882 0
Country [1] 298882 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300470 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 300470 0
St Bernards Rd, Magill SA 5072
Ethics committee country [1] 300470 0
Australia
Date submitted for ethics approval [1] 300470 0
Approval date [1] 300470 0
03/01/2017
Ethics approval number [1] 300470 0

Summary
Brief summary
The aim of this study is to compare the concentration of fentanyl between maternal and cord blood in women administered intranasal (IN) or subcutaneous (SC) fentanyl for labour analgesia.

A prospective observational study will be conducted at Gawler Health Service.

Fentanyl is routinely offered (via the intranasal or subcutaneous routes) to women requesting pain relief in labour at Gawler Health Service. Maternal and cord blood samples will be collected at the time of birth to determine the plasma concentration of fentanyl in order to assess the relative exposure of the neonate to the maternal administration..

Maternal and cord blood samples will be collected in heparin tubes, within 30 minutes of each other and refrigerated at 4°C. Tthe samples will then be processed at SA Pathology where they will be centrifuged at 3000 rev min-1 for 10 minutes, the plasma removed and frozen at -20°C until the time of assay.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83762 0
Dr Julie Fleet
Address 83762 0
University of South Australia, School of Nursing & Midwifery,
108 North Terrance Adelaide 5000
Country 83762 0
Australia
Phone 83762 0
+61883021845
Fax 83762 0
Email 83762 0
[email protected]
Contact person for public queries
Name 83763 0
Julie Fleet
Address 83763 0
University of South Australia, School of Nursing & Midwifery, 108 North Terrance Adelaide 5000
Country 83763 0
Australia
Phone 83763 0
+61883021845
Fax 83763 0
Email 83763 0
[email protected]
Contact person for scientific queries
Name 83764 0
Julie Fleet
Address 83764 0
University of South Australia, School of Nursing & Midwifery,
108 North Terrance Adelaide 5000
Country 83764 0
Australia
Phone 83764 0
+61883021845
Fax 83764 0
Email 83764 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Testing fentanyl levels via maternal and cord bloo... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIMATERNAL AND UMBILICAL CORD PLASMA FENTANYL CONCENTRATION FOLLOWING INTRANASAL OR SUBCUTANEOUS ADMINISTRATION IN LABOUR2019https://doi.org/10.1111/jpc.14407_10
N.B. These documents automatically identified may not have been verified by the study sponsor.