Carbetocin Versus Oxytocin and Hemodynamic Effects
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ClinicalTrials.gov Identifier: NCT00977769 |
Recruitment Status :
Completed
First Posted : September 16, 2009
Results First Posted : May 6, 2014
Last Update Posted : May 6, 2014
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Sponsor:
Oslo University Hospital
Information provided by (Responsible Party):
Leiv Arne Rosseland, Oslo University Hospital
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Effects of; Anesthesia, in Pregnancy |
Interventions |
Drug: carbetocin 100 µg Drug: oxytocin 5 u Drug: placebo (NaCl) |
Enrollment | 76 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Carbetocin 100 µg | Oxytocin 5 u | Placebo (NaCl) |
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carbetocin 100 µg : Hemodynamic effect of | oxytocin 5 u : Hemodynamic effect of | placebo (NaCl) : Hemodynamic effect of |
Period Title: Overall Study | |||
Started | 25 | 26 | 25 |
Completed | 25 | 26 | 25 |
Not Completed | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Carbetocin 100 µg | Oxytocin 5 u | Placebo (NaCl) | Total | |
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carbetocin 100 µg : Hemodynamic effect of | oxytocin 5 u : Hemodynamic effect of | placebo (NaCl) : Hemodynamic effect of | Total of all reporting groups | |
Overall Number of Baseline Participants | 25 | 26 | 25 | 76 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 25 participants | 26 participants | 25 participants | 76 participants | |
<=18 years |
0 0.0%
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0 0.0%
|
0 0.0%
|
0 0.0%
|
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Between 18 and 65 years |
25 100.0%
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26 100.0%
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25 100.0%
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76 100.0%
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>=65 years |
0 0.0%
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0 0.0%
|
0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 25 participants | 26 participants | 25 participants | 76 participants | |
34.2 (3.8) | 35.0 (5.0) | 34.8 (4.0) | 34.5 (4.6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 25 participants | 26 participants | 25 participants | 76 participants | |
Female |
25 100.0%
|
26 100.0%
|
25 100.0%
|
76 100.0%
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|
Male |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Norway | Number Analyzed | 25 participants | 26 participants | 25 participants | 76 participants |
25 | 26 | 25 | 76 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Professor Leiv Arne Rosseland |
Organization: | Oslo University Hospital |
Phone: | +4723070000 |
EMail: | lrossela@ous-hf.no |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Leiv Arne Rosseland, Oslo University Hospital |
ClinicalTrials.gov Identifier: | NCT00977769 |
Other Study ID Numbers: |
2009carb |
First Submitted: | September 15, 2009 |
First Posted: | September 16, 2009 |
Results First Submitted: | April 24, 2013 |
Results First Posted: | May 6, 2014 |
Last Update Posted: | May 6, 2014 |