CClinicalTrials.gg
Status unknownNCT02573831oksisynnIIUpdated Mar 16, 2023

The Effect of Oxycodone to the Placental Circulation at Early Labour

A Phase 4 interventional study of Oxycodone and Placebo in Labor Pain, sponsored by Kuopio University Hospital. Status unknown at 1 site in Finland. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-03-16.

Sponsored by Kuopio University Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Feb 2015, registered Oct 2015).
Phase
Phase 4
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Labor Pain

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Keywords

  • labor
  • pain
  • oxycodone
  • placenta
03

In context

Labor Pain

396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.

This study's enrollment of 22 is below the median of 100 across 326 interventional studies indexed under Labor Pain.

Browse Labor Pain studies →

Lead sponsor

Kuopio University Hospital is the lead sponsor of 132 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • oxycodone planned for pain relief

    • age 18 years or more
    • Informed consent obtained
    • Full term pregnancy

Exclusion criteria

Exclusion Criteria:

  • No oxycodone planned

    • age less than 18 years
    • No informed consent
    • not full term pregnancy
  • Other contraindication to oxycodone
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
22 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    The patients are given at first placebo and after one hour oxycodone 0,05 mg/kg if needed

    Drug: Placebo

  • Experimental
    Oxycodone

    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

    Drug: Oxycodone

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

06

What researchers measure

Primary outcomes

  1. placental blood flow

    Placental blood flow is measured with doppler ultrasound

    Time frame: from zero hours to two hours after the first study drug

Secondary outcomes

  1. uterine arterial flow

    uterine arterial flow is measured with doppler ultrasound

    Time frame: from zero hours to two hours after the first study drug

07

Study locations

1 site
  • Kuopio University Hospital
    Kuopio, Northern Savo 70029, Finland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02573831
Lead sponsor
Kuopio University Hospital
Collaborators
Admescope Ltd
Responsible party
Merja Kokki (MD, PhD, Kuopio University Hospital) — Principal investigator
First posted
Oct 12, 2015
Start date
Feb 1, 2015
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Mar 16, 2023

Study contacts

Merja Kokki, MD, PhD
principal investigator · Kuopio University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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