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A comparison of maternal and fetal fentanyl concentration following fentanyl use in childbirth

Fentanyl concentration in maternal and umbilical cord plasma following intranasal or subcutaneous administration in labour

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618001012268
Enrollment
33
Registered
2018-06-18
Start date
2017-03-02
Completion date
2018-06-30
Last updated
2018-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

The University of South Australia
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes

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)

Exclusion criteria

Pre-term birth Multiple birth Operative birth Have a known allergy to fentanyl

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026