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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02264834 |
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Date of registration:
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01/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Deambulatory Epidural During the Labour
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Scientific title:
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Comparison of Two Different Peridural During the Labor and Effect of Deambulation |
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Date of first enrolment:
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July 1, 2014 |
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Target sample size:
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164 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02264834 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Philippe Vanderlinden |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHUB |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Free written consent.
- 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:
- Twin pregnancy, less than 36 weeks and 42 weeks
- Fetus in breech position
- Analgesia and sedation within 6h
- Contraindications to peridural
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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First Pregnancy
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Intervention(s)
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Drug: Levobupivacaine 0.07% + Sufentanil 0.3µg/ml
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Drug: Levobupivacaine 0.1% + Sufentanil 0.2µg/ml
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Procedure: Lumbar epidural analgesia
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Primary Outcome(s)
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Time between peridural application and childbirth
[Time Frame: at delivery]
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Apgar score of the baby
[Time Frame: at delivery]
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Caesarian
[Time Frame: at delivery]
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Instrumentalisation
[Time Frame: at delivery]
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Secondary Outcome(s)
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Arterial tension
[Time Frame: 1h after the start of the peridural]
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Romberg test
[Time Frame: 1h after the start of the peridural]
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Bromage score
[Time Frame: 1h after the start of the peridural]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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