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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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1 February 2016 |
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Main ID: |
NCT01686347 |
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Date of registration:
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07/06/2012 |
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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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Epidural Analgesia and Troubles of Fetal Cardiaq Rythm : Effect of the Systemic Transfer of Ropivacaine and Sufentanil
epidarc |
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Scientific title:
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Epidural Analgesia and Troubles of Fetal Cardiaq Rythm : Effect of the Systemic Transfer of Ropivacaine and Sufentanil |
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Date of first enrolment:
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June 2012 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01686347 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Phase:
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Phase 4
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18 years old or more
- nulliparous
_ one fetus
- head first
- spontaneous labor
- epidural analgesia
- no fetal cardiac rhythm abnormalies before the epidural analgesia
- no active management of labor during 30 minutes after the epidural analgesia
induction
- at term
- signature of the consent form
Exclusion Criteria:
- pathological pregnancy
- low maternal blood pressure during the 30 minutes after the epidural analgesia
- uterin contraction which last for 5 minutes or more
- more than 6 uterin contractions during a 10 minutes period
- Ropivacaine contraindication
- sufentanil contraindication
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Fetal Cardiac Rhythm Abnormalities
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Intervention(s)
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Drug: ropivacaine
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Primary Outcome(s)
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Plasmatic concentrations compared maternal ropivacaine based on the presence of abnormal fetal heart rate
[Time Frame: 1 day]
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Secondary Outcome(s)
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Plasmatic concentrations compared maternal sufentanil based on the presence of abnormal fetal heart rate
[Time Frame: 1 day]
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Secondary ID(s)
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2010/146/HP
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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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