Labor PainoksisynnytysNCT02575677
Oxycodone in Treatment of Early Labour Pain Efficacy and Safety
An observational study of Labor Pain, run by Kuopio University Hospital at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- oxycodone
- How many people
- 90 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2012to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Parturients who are in early labor and need some pain medication.
Who may be able to join
- Oxycodone for pain relief
- age 18 years or more
- given informed consent
Who cannot join
- no oxycodone
- age less than 18 years
- no informed consent
Trial locations and contacts
1 site in 1 country.
Merja Kokki, PhD contact
Finland1 site, 1 recruiting
- Recruiting
Kuopio University Hospital
Kuopio, Northern Savonia, 70029
Merja Kokki, PhD, +358447174764
About this study
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.
- Conditions
- Labor Pain
- Being tested
- oxycodone
- Keywords
- labor pain, oxycodone
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxycodoneOther
Also called Ocycodone administration
oxycodone 0,1/kg up to 10 mg sc.
| Study group | Role | What they receive |
|---|---|---|
| Parturients with oxycodone | Parturients who were given oxycodone Receives: Other: oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measured with numerical rating scale
Pain measured with numerical rating scale 0-10 (0=no pain, 10 = worst pain)
Measured: from the time of oxycodone administration up to the birth of newborn, maximum of 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startOct 2012
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Admescope Ltd
- Responsible party
- Principal investigator, Merja Kokki, Kuopio University Hospital
- Investigators
- Merja Kokki, MD, PhD, Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575677
- Sponsor's protocol ID
- KUH26062012
- Acronym
- oksisynnytys
- Status last verified
- Mar 2023
- First submitted
- 8 Oct 2015
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxycodone in Treatment of Early Labour Pain Efficacy and Safety
- ClinicalTrials.gov ID
- NCT02575677
- Acronym / sponsor ID
- oksisynnytys / KUH26062012
- Conditions
- Labor Pain
- Keywords
- labor pain, oxycodone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Admescope Ltd
- Study start
- Oct 2012 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 15 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parturients with oxycodone | – | Other: oxycodoneParturients who were given oxycodone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parturients who are in early labor and need some pain medication.
Key inclusion criteria (3 listed)
- Oxycodone for pain relief
- age 18 years or more
- given informed consent
Key exclusion criteria (3 listed)
- no oxycodone
- age less than 18 years
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxycodoneAlso: Ocycodone administrationoxycodone 0,1/kg up to 10 mg sc. | Other | Parturients with oxycodone |
Primary outcome
Pain measured with numerical rating scale
Time frame: from the time of oxycodone administration up to the birth of newborn, maximum of 48 hours
Pain measured with numerical rating scale 0-10 (0=no pain, 10 = worst pain)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merja Kokki, PhD contact
Merja Kokki, MD, PhD principal investigator
Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor Pain, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merja Kokki, PhD (+358-44-7174764), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain measured with numerical rating scale (time frame: from the time of oxycodone administration up to the birth of newborn, maximum of 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.