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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
Sponsor:
Information provided by (Responsible Party):
Leiv Arne Rosseland, Oslo University Hospital

Tracking Information
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
 (submitted: April 4, 2014)
  • Cardiac Output [ Time Frame: 2.5 minutes ]
    The relative change in CO from baseline at the time of delivery up to 2.5 minutes post delivery.
  • Arterial Blood Pressure [ Time Frame: 2.5 min ]
    The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery.
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2009)		 Cardiac output [ Time Frame: 10 minutes ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2014)		 Bleeding [ Time Frame: 120 minutes ]
The calculated estimated blood loss from delivery until 2 h after intervention
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2009)
  • Blood pressure [ Time Frame: 30 minutes ]
  • Peripheral vascular resistance [ Time Frame: 30 minutes ]
  • Bleeding [ Time Frame: 30 minutes ]
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
Condition  ICMJE Effects of; Anesthesia, in Pregnancy
Intervention  ICMJE
  • Drug: carbetocin 100 µg
    Hemodynamic effect of
    Other Name: Pabal, injection
  • Drug: oxytocin 5 u
    Hemodynamic effect of
    Other Name: Syntocinon, injection
  • Drug: placebo (NaCl)
    Hemodynamic effect of
    Other Name: Saline, injection
Study Arms  ICMJE
  • Experimental: carbetocin 100 µg
    Carbetocin injection, 100µg, single injection
    Intervention: Drug: carbetocin 100 µg
  • Active Comparator: oxytocin 5 u
    Oxytocin 5U, injection, single injection
    Intervention: Drug: oxytocin 5 u
  • Placebo Comparator: placebo (NaCl)
    Saline single injection
    Intervention: Drug: placebo (NaCl)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 26, 2011)		 76
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2009)		 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:

  • Healthy pregnant women for planned cesarean section

Exclusion Criteria:

  • Bleeding disorders
  • Placenta disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
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
Principal Investigator: Leiv Arne Rosseland, MD PhD Oslo University Hospital
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