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The Effect of Oxycodone to the Placental Circulation at Early Labour

Phase 4
Active, not recruiting
Conditions
Labor Pain
Interventions
Drug: Placebo
Registration Number
NCT02573831
Lead Sponsor
Kuopio University Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
Female
Target Recruitment
22
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboThe patients are given at first placebo and after one hour oxycodone 0,05 mg/kg if needed
OxycodoneOxycodoneThe 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
Primary Outcome Measures
NameTimeMethod
placental blood flowfrom zero hours to two hours after the first study drug

Placental blood flow is measured with doppler ultrasound

Secondary Outcome Measures
NameTimeMethod
uterine arterial flowfrom zero hours to two hours after the first study drug

uterine arterial flow is measured with doppler ultrasound

Trial Locations

Locations (1)

Kuopio University Hospital

🇫🇮

Kuopio, Northern Savo, Finland

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