Labor PainPhase 4oksisynnIINCT02573831
The Effect of Oxycodone to the Placental Circulation at Early Labour
A Phase 4 study testing Oxycodone in people with Labor Pain, run by Kuopio University Hospital at 1 site in Finland.
Trial 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. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteFinland
- Study dates
- 1 Feb 2015to 31 Dec 2023
- Phase
- Phase 4
- 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
Who may be able to join
- oxycodone planned for pain relief
- age 18 years or more
- Informed consent obtained
- Full term pregnancy
Who cannot join
- No oxycodone planned
- age less than 18 years
- No informed consent
- not full term pregnancy
- Other contraindication to oxycodone
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Labor Pain
- Being tested
- Oxycodone, Placebo
- Keywords
- labor, pain, oxycodone, placenta
- Medical subject headings
- Labor Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
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
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The patients are given at first placebo and after one hour oxycodone 0,05 mg/kg if needed Receives: Drug: Placebo |
| Oxycodone | Experimental | 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 Receives: Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
placental blood flow
Placental blood flow is measured with doppler ultrasound
Measured: from zero hours to two hours after the first study drug
Secondary outcomes (1)
uterine arterial flow
uterine arterial flow is measured with doppler ultrasound
Measured: from zero hours to two hours after the first study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study start1 Feb 2015
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
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
- NCT02573831
- Sponsor's protocol ID
- KUH12012015
- Acronym
- oksisynnII
- Status last verified
- Mar 2023
- First submitted
- 8 Oct 2015
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 37344997
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
- The Effect of Oxycodone to the Placental Circulation at Early Labour
- ClinicalTrials.gov ID
- NCT02573831
- Acronym / sponsor ID
- oksisynnII / KUH12012015
- Conditions
- Labor Pain
- Keywords
- labor, pain, oxycodone, placenta
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Admescope Ltd
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 12 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboThe patients are given at first placebo and after one hour oxycodone 0,05 mg/kg if needed |
| Oxycodone | Experimental | Drug: OxycodoneThe 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- oxycodone planned for pain relief
Key exclusion criteria (5 listed)
- No oxycodone planned
- Other contraindication to oxycodone
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 |
|---|---|---|
| OxycodoneThe 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 | Drug | Oxycodone |
| PlaceboThe 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 | Drug | Placebo |
Primary outcome
placental blood flow
Time frame: from zero hours to two hours after the first study drug
Placental blood flow is measured with doppler ultrasound
1 secondary outcome
uterine arterial flow
Time frame: from zero hours to two hours after the first study drug
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.
- Derived from this study: PubMed 37344997Alanne 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.
- 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, 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?
A Phase 4 study testing Oxycodone in people with 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 4 inclusion and 5 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
placental blood flow (time frame: from zero hours to two hours after the first study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02573831, which also lists 1 linked publication.
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.