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The Effect of Oxycodone to the Placental Circulation at Early Labour

The Effect of Oxycodone to the Placental Circulation at Early Labour

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02573831
Acronym
oksisynnII
Enrollment
22
Registered
2015-10-12
Start date
2015-02-01
Completion date
2023-12-31
Last updated
2023-03-16

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

Conditions

Labor Pain

Keywords

labor, pain, oxycodone, placenta

Brief summary

Oxycodone is used to treat pain in early labor, however the effect of oxycodone to placental or fetal circulation has not been evaluated. Oxycodone is increasingly used to treat labor pain in the early phase. The aim of the randomised, double blinded, placebo controlled study was to evaluate the effects of oxycodone in placental circulation, efficacy and safety of oxycodone and the effects to the newborn.

Interventions

DRUGOxycodone

The patients are given at first oxycodone 0,05 mg/kg and after one hour oxycodone 0,05 mg/kg if their pain in numerical rating scale from 0 to 10 is 5 or more

DRUGPlacebo

The patients are given at first placebo and after one hour oxycodone 0,05 mg/kg if their pain in numerical rating scale from 0 to 10 is 5 or more

Sponsors

Admescope Ltd
CollaboratorINDUSTRY
Kuopio University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* oxycodone planned for pain relief * age 18 years or more * Informed consent obtained * Full term pregnancy

Exclusion criteria

* No oxycodone planned * age less than 18 years * No informed consent * not full term pregnancy * Other contraindication to oxycodone

Design outcomes

Primary

MeasureTime frameDescription
placental blood flowfrom zero hours to two hours after the first study drugPlacental blood flow is measured with doppler ultrasound

Secondary

MeasureTime frameDescription
uterine arterial flowfrom zero hours to two hours after the first study druguterine arterial flow is measured with doppler ultrasound

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026