effect of a low concentration epidural during the labor in pregnant women compared to conventional epidural

comparative study between conventional epidural versus ambulatory epidural: effect during labor in pregnant women - ambulatory epidural

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000470-19-BE

Enrollment

350

Registered

2014-03-12

Start date

2014-04-17

Completion date

Unknown

Last updated

2018-02-26

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

Conditions

a single fetus pregnancy over 36 weeks and less than 42 weeks in adult nulliparous

Interventions

Trade Name: LEVOBUPIVACAINE Product Name: LEVOBUPIVACAINE Pharmaceutical Form: Solution for injection Trade Name: SUFENTANIL Product Name: sufenta Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Secondary end point(s): the effect of walking to the delivery;Timepoint(s) of evaluation of this end point: after delivery	—

Countries

Belgium

Outcome results

None listed

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