Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
164 participants
INTERVENTIONAL
2014-07-01
2018-03-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Control group
Lumbar epidural analgesia during the labour and end up after delivery Levobupivacaine 0.1% + Sufentanil 0.2 µg/mL
Levobupivacaine 0.1% + Sufentanil 0.2µg/ml
Levobupivacaine 0.1% + Sufentanil 0.2µg/ml
Lumbar epidural analgesia
Introduction of a catheter in lumbar epidural space
Ambulatory group
Lumbar epidural analgesia during the labour and end up after delivery Levobupivacaine 0.07% + Sufentanil 0.3 µg/mL
Levobupivacaine 0.07% + Sufentanil 0.3µg/ml
Levobupivacaine 0.07% + Sufentanil 0.3µg/ml
Lumbar epidural analgesia
Introduction of a catheter in lumbar epidural space
Interventions
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Levobupivacaine 0.1% + Sufentanil 0.2µg/ml
Levobupivacaine 0.1% + Sufentanil 0.2µg/ml
Levobupivacaine 0.07% + Sufentanil 0.3µg/ml
Levobupivacaine 0.07% + Sufentanil 0.3µg/ml
Lumbar epidural analgesia
Introduction of a catheter in lumbar epidural space
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA I or II,
* Primipara, unique and pregnancy over 36 weeks fetus in cephalic, cervical dilation between 3-6 cm
* VAS\> 30 mm
* No contraindications to peridural
Exclusion Criteria
* Fetus in breech position
* Analgesia and sedation within 6h
* Contraindications to peridural
18 Years
40 Years
FEMALE
Yes
Sponsors
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Dr Madeleine Wilwerth
OTHER
Responsible Party
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Dr Madeleine Wilwerth
primary investigator
Principal Investigators
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Philippe Vanderlinden
Role: STUDY_DIRECTOR
CHUB
Locations
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CHUB
Brussels, , Belgium
Countries
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Other Identifiers
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PDB001
Identifier Type: -
Identifier Source: org_study_id
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