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The Effect of Oxycodone to the Placental Circulation at Early Labour (oksisynnII)

Primary Purpose

Labor Pain

Status
Active
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Oxycodone
Placebo
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring labor, pain, oxycodone, placenta

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kuopio University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Oxycodone

Arm Description

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

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

Outcomes

Primary Outcome Measures

placental blood flow
Placental blood flow is measured with doppler ultrasound

Secondary Outcome Measures

uterine arterial flow
uterine arterial flow is measured with doppler ultrasound

Full Information

First Posted
October 8, 2015
Last Updated
March 14, 2023
Sponsor
Kuopio University Hospital
Collaborators
Admescope Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02573831
Brief Title
The Effect of Oxycodone to the Placental Circulation at Early Labour
Acronym
oksisynnII
Official Title
The Effect of Oxycodone to the Placental Circulation at Early Labour
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2015 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital
Collaborators
Admescope Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
labor, pain, oxycodone, placenta

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The patients are given at first placebo and after one hour oxycodone 0,05 mg/kg if needed
Arm Title
Oxycodone
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
placental blood flow
Description
Placental blood flow is measured with doppler ultrasound
Time Frame
from zero hours to two hours after the first study drug
Secondary Outcome Measure Information:
Title
uterine arterial flow
Description
uterine arterial flow is measured with doppler ultrasound
Time Frame
from zero hours to two hours after the first study drug

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merja Kokki, MD, PhD
Organizational Affiliation
Kuopio University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
State/Province
Northern Savo
ZIP/Postal Code
70029
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Oxycodone to the Placental Circulation at Early Labour

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