The Effect of Oxycodone to the Placental Circulation at Early Labour

NCT ID: NCT02573831

Last Updated: 2023-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-01

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Labor Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Admescope Ltd

INDUSTRY

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Merja Kokki

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Merja Kokki, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kuopio University Hospital

Locations

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Kuopio University Hospital

Kuopio, Northern Savonia, Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 37344997 (View on PubMed)

Other Identifiers

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KUH12012015

Identifier Type: -

Identifier Source: org_study_id

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