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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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16 December 2017 |
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Main ID: |
NCT02854787 |
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Date of registration:
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30/07/2016 |
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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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Intravenous Bolus of Phenylephrine vs. Norepinephrine in Preventing Hypotension After Spinal Anesthesia
NorPN |
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Scientific title:
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Intravenous Bolus of Phenylephrine vs. Norepinephrine in Preventing Hypotension After Spinal Anesthesia for Cesarean Section |
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Date of first enrolment:
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May 2016 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02854787 |
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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: Prevention. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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Tunisia
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- of Anesthesiologists (ASA) Physical Status classification 1 and 2
- Pregnant women with singleton pregnancy
Exclusion Criteria:
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Complications, Cesarean Section
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Anesthesia, Spinal and Epidural
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Hypotension
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Adverse Effect
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Intervention(s)
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Drug: Phenylephrine
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Drug: Norepinephrine
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Primary Outcome(s)
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Maternal Blood Pressure
[Time Frame: At time of surgery (right after spinal anesthesia until end of surgery)]
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Secondary Outcome(s)
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Hemodynamic Parameters - arrhythmia
[Time Frame: At time of surgery (right after spinal anesthesia until end of surgery)]
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Hemodynamic Parameters - heart rate
[Time Frame: At time of surgery (right after spinal anesthesia until end of surgery]
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mean pH of the fetal cord blood in each group
[Time Frame: At time of birth]
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Vomiting
[Time Frame: At time of surgery (right after spinal anesthesia until end of surgery)]
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Nausea
[Time Frame: At time of surgery (right after spinal anesthesia until end of surgery)]
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Secondary ID(s)
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UniversityTunis el manar
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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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