Oxycodone in Treatment of Early Labour Pain Efficacy and... | NCT02575677

Studies
Oxycodone in Treatment of Early Labour Pain Efficacy and Safety

NCT02575677

Sponsor

Kuopio University Hospital

Status

Unknown status

Last Update Posted

Mar 16, 2023Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Labor Pain

Interventions

oxycodone

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Oct 8, 2015

First Submission Date that Met QC Criteria

Oct 12, 2015

First Posted Date

Oct 15, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2023

Last Update Posted Date

Mar 16, 2023Actual

Name	Class
Admescope Ltd	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Oxycodone is used to treat early labour pain instead of meperidine. However, the efficacy and effects of oxycodone to the newborn has not been studied. In the present study, patient who has received oxycodone is asked about pain relief and after labour single venous blood sample from the parturient and umbilical cord are taken for the analysis of oxycodone.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parturients with oxycodone		Parturients who were given oxycodone	Other: oxycodone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oxycodone	Other	oxycodone 0,1/kg up to 10 mg sc.	Parturients with oxycodone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain measured with numerical rating scale	Pain measured with numerical rating scale 0-10 (0=no pain, 10 = worst pain)	from the time of oxycodone administration up to the birth of newborn, maximum of 48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Oxycodone for pain relief
age 18 years or more
given informed consent

Exclusion Criteria:

no oxycodone
age less than 18 years
no informed consent

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Parturients who are in early labor and need some pain medication.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Merja Kokki, PhD	Contact	+358-44-7174764
Hannu Kokki, professor	Contact	+358503790374		hannu.kokki@uef.fi

Overall Officials

Name	Affiliation	Role
Merja Kokki, MD, PhD	Kuopio University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kuopio University Hospital	Recruiting	Kuopio	Northern Savonia	70029	Finland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D048949	Labor Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010098	Oxycodone

Ancestor Terms

ID	Term
D003061	Codeine
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids

Browse Leaves

Not provided

Browse Branches

Not provided