Oxycodone compared to meperidine in the treatment of labour pai

Phase 1

Conditions: abour pain
MedDRA version: 19.0Level: LLTClassification code 10023554Term: Labour pains stoppedSystem Organ Class: 100000004868
Therapeutic area: Body processes [G] - Biological Phenomena [G16]

Registration Number: EUCTR2016-002374-12-FI

Lead Sponsor: Helsinki University Central Hospital/ Women's hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;Main Objective: Alleviation of uterine contraction associated intensity of labour pain in the early phase of labour

Secondary Outcome Measures

Name	Time	Method
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