ANZCTR - Registration

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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Childbirth

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

Plasma concentration of fentanyl to assess the relative exposure of the neonate to the maternal administration.

Timepoint [1]

At time of birth

Secondary outcome [1]

nil

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Gawler Health Service - Gawler East

Recruitment postcode(s) [1]

5118 - Gawler East

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of South Australia

Address [1]

108 North Terrace, Adelaide SA 5001

Country [1]

Australia

Primary sponsor type

University

Name

The University of South Australia

Address

108 North Terrace, Adelaide SA 5001

Country

Australia

Secondary sponsor category [1]

None

Name [1]

not applicable

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of South Australia Human Research Ethics Committee

Ethics committee address [1]

St Bernards Rd, Magill SA 5072

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

03/01/2017

Ethics approval number [1]

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

Dr Julie Fleet

Address

University of South Australia, School of Nursing & Midwifery,
108 North Terrance Adelaide 5000

Country

Australia

Phone

+61883021845

Fax

[email protected]

Contact person for public queries

Name

Julie Fleet

Address

University of South Australia, School of Nursing & Midwifery, 108 North Terrance Adelaide 5000

Country

Australia

Phone

+61883021845

Fax

[email protected]

Contact person for scientific queries

Name

Julie Fleet

Address

University of South Australia, School of Nursing & Midwifery,
108 North Terrance Adelaide 5000

Country

Australia

Phone

+61883021845

Fax

[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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Testing fentanyl levels via maternal and cord bloo... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	MATERNAL AND UMBILICAL CORD PLASMA FENTANYL CONCENTRATION FOLLOWING INTRANASAL OR SUBCUTANEOUS ADMINISTRATION IN LABOUR	2019	https://doi.org/10.1111/jpc.14407_10

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically