Relief of labor pain by spinal or epidural analgesia in the early phase of induced labor
- Conditions
- abor pain during induced laborMedDRA version: 21.1Level: PTClassification code 10059204Term: Labour painSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsTherapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
- Registration Number
- EUCTR2020-005506-26-FI
- Lead Sponsor
- Antti Väänänen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 60
The parturient is willing to participate
The parturient is undergoing induction of labour
Age of the parturient equal or over 18 years
Singleton pregnancy
First vaginal delivery
At the time of administration of the IMP the parturient has cervical dilatation of 4 cm or less
No prior opioid analgesics have been given within 90 minutes
The parturient has maximum pain during contraction of 8-10/10 on NRS scale.
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
Unwilling to participate in the study or the parturient withdraws consent
HAs received opioid analgesics within 90 minutes
The labour has progressed beyond the 4 cm cervical dilatation phase
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method