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NCT02573831 Clinical Trial

The Effect of Oxycodone to the Placental Circulation at Early Labour

Labor Pain Clinical Trial

— oksisynnII  

Official title:
The Effect of Oxycodone to the Placental Circulation at Early Labour

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02573831
Other study ID # KUH12012015
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date February 1, 2015
Est. completion date December 31, 2023

Study information
Verified date March 2023
Source Kuopio University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 22
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• 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
• Placebo
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

Locations
Country Name City State
Finland Kuopio University Hospital Kuopio Northern Savo

Sponsors (2)
Lead Sponsor Collaborator
Kuopio University Hospital Admescope Ltd

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary placental blood flow Placental blood flow is measured with doppler ultrasound from zero hours to two hours after the first study drug
Secondary uterine arterial flow uterine arterial flow is measured with doppler ultrasound from zero hours to two hours after the first study drug
See also
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Active, not recruiting NCT02271100 - Assessment of the Use of Ultrasound for Epidural Catheter Placement and Comparison With Palpation Technique N/A
Completed NCT02926469 - Virtual Reality Analgesia in Labor: The VRAIL Pilot Study N/A
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Not yet recruiting NCT05565274 - Outcome of Combined Tramadol and Paracetamol Versus Pentazocine as Labour Analgesia Among Parturients N/A
Recruiting NCT01708668 - The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia N/A
Recruiting NCT02575677 - Oxycodone in Treatment of Early Labour Pain Efficacy and Safety