effect of a low concentration epidural during the labor in pregnant women compared to conventional epidural
Phase 1
- Conditions
- a single fetus pregnancy over 36 weeks and less than 42 weeks in adult nulliparousTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2014-000470-19-BE
- Lead Sponsor
- Centre Hospitalier Universitaire Brugmann
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 350
Inclusion Criteria
Free written consent.
Parturient aged 18-40 years, nulliparous, ASA I or II, and singleton pregnancy over 36 weeks fetus in cephalic position, cervical dilatation between 3-6 cm and VAS> 30 mm, no objections for epidural
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 350
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Multiparous, twin pregnancy, less than 36 weeks and over 42 weeks, the fetus in the breech position, previous history of caesarean / instrumentation, analgesia or sedation within 6h, contraindications to epidural
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: the impact of walking during the labor ;Primary end point(s): the impact of instrumentation and caesarean during the delivery ;Timepoint(s) of evaluation of this end point: after delivery ;Main Objective: the impact of instrumentation and caesarean decreasing the dose of local anesthetic during the labor
- Secondary Outcome Measures
Name Time Method Secondary end point(s): the effect of walking to the delivery;Timepoint(s) of evaluation of this end point: after delivery