Oxycodone compared to meperidine in the treatment of labour pain

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002374-12-FI

Enrollment

Registered

2016-10-25

Start date

2016-12-23

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labour pain MedDRA version: 19.0 Level: LLT Classification code 10023554 Term: Labour pains stopped System Organ Class: 100000004868

Interventions

Trade Name: Petidin meda 50 mg/ml Product Name: Petidin meda 50 mg/ml Pharmaceutical Form: Solution for injection INN or Proposed INN: PETHIDINE CAS Number: 57-42-1 Concentration unit: mg/ml milligram

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Previously healthy primiparous parturients, who volunteer to participate in the study and who have normal fetal heart rate and who have planned to take epidural or other regional anesthesia for labour pain Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Age under 18 or over 45 Obesity BMI over 35, Diabetes with insulin, epilepsy, liver or kidney disease Complicated pregnancy (such as pre-eclampsia or hepatogestosis) Use of medication which could alter the pharmacokinetics of the studied drugs Abnormal heart rate of fetus (CTG) Green amniotic fluid Small size of the fetus for the gestation age Reduced motility of the fetus Abnormal flow in the umbilical vessels

Design outcomes

Primary

Measure	Time frame
Main Objective: Alleviation of uterine contraction associated intensity of labour pain in the early phase of labour;Secondary Objective: Time delay from administration of IMP to request for next analgesia (epidural analgesia);Primary end point(s): Request for additional analgesia for labour pain following the administration of IMP;Timepoint(s) of evaluation of this end point: Approximately 2-4 hours after administration of IMP	—

Measure

Time frame

Main Objective: Alleviation of uterine contraction associated intensity of labour pain in the early phase of labour;Secondary Objective: Time delay from administration of IMP to request for next analgesia (epidural analgesia);Primary end point(s): Request for additional analgesia for labour pain following the administration of IMP;Timepoint(s) of evaluation of this end point: Approximately 2-4 hours after administration of IMP

—

Secondary

Measure	Time frame
Secondary end point(s): Mode of delivery, apgar score of the infant;Timepoint(s) of evaluation of this end point: Less than 24 hrs after administration of IMP	—

Countries

Finland

Contacts

Public ContactHUCH/Kätilöopiston sairaala

Dr Jouni Ahonen

jouni.ahonen@hus.fi358504271852

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026