The Effect of Oxycodone to the Placental Circulation at Early Labour
oksisynnII
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2015
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 8, 2015
CompletedFirst Posted
Study publicly available on registry
October 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMarch 16, 2023
March 1, 2023
8.9 years
October 8, 2015
March 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
placental blood flow
Placental blood flow is measured with doppler ultrasound
from zero hours to two hours after the first study drug
Secondary Outcomes (1)
uterine arterial flow
from zero hours to two hours after the first study drug
Study Arms (2)
Placebo
PLACEBO COMPARATORThe patients are given at first placebo and after one hour oxycodone 0,05 mg/kg if needed
Oxycodone
EXPERIMENTALThe 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
Interventions
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
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
Eligibility Criteria
You may qualify if:
- oxycodone planned for pain relief
- age 18 years or more
- Informed consent obtained
- Full term pregnancy
You may not qualify if:
- No oxycodone planned
- age less than 18 years
- No informed consent
- not full term pregnancy
- Other contraindication to oxycodone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kuopio University Hospitallead
- Admescope Ltdcollaborator
Study Sites (1)
Kuopio University Hospital
Kuopio, Northern Savonia, 70029, Finland
Related Publications (1)
Alanne L, Kokki H, Mykkanen A, Orden MR, Rinne V, Rasanen J, Kokki M. Oxycodone does not affect placental circulatory physiology during the early first stage of labor-A randomized trial. Acta Obstet Gynecol Scand. 2023 Aug;102(8):1063-1072. doi: 10.1111/aogs.14603. Epub 2023 Jun 21.
PMID: 37344997DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Merja Kokki, MD, PhD
Kuopio University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
October 8, 2015
First Posted
October 12, 2015
Study Start
February 1, 2015
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
March 16, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share