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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Tracking Information | ||||
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First Submitted Date ICMJE | September 15, 2009 | |||
First Posted Date ICMJE | September 16, 2009 | |||
Results First Submitted Date ICMJE | April 24, 2013 | |||
Results First Posted Date ICMJE | May 6, 2014 | |||
Last Update Posted Date | May 6, 2014 | |||
Study Start Date ICMJE | November 2009 | |||
Actual Primary Completion Date | August 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Cardiac output [ Time Frame: 10 minutes ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Bleeding [ Time Frame: 120 minutes ] The calculated estimated blood loss from delivery until 2 h after intervention
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Carbetocin Versus Oxytocin and Hemodynamic Effects | |||
Official Title ICMJE | Hemodynamic Effects of Carbetocin 100 µg, Oxytocin 5 U or Placebo After Cesarean Delivery Under Spinal Anesthesia in Healthy Pregnant Women. | |||
Brief Summary | A randomized double-blind trial of oxytocin 5 u, carbetocin 100 µg and placebo with hemodynamic response as a primary outcome measure. | |||
Detailed Description | Healthy pregnant women sheduled for elective cesarean section. Invasive hemodynmaic monitoring with LiDCO Plus. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Effects of; Anesthesia, in Pregnancy | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
76 | |||
Original Estimated Enrollment ICMJE |
75 | |||
Actual Study Completion Date ICMJE | October 2011 | |||
Actual Primary Completion Date | August 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Norway | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00977769 | |||
Other Study ID Numbers ICMJE | 2009carb | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Leiv Arne Rosseland, Oslo University Hospital | |||
Original Responsible Party | Øyvind Skraastad, Oslo University Hospital, Dvision of Anaesthesia and Intensive Care Medicine | |||
Current Study Sponsor ICMJE | Oslo University Hospital | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Oslo University Hospital | |||
Verification Date | April 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |