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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

Study Description
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Brief Summary:
A randomized double-blind trial of oxytocin 5 u, carbetocin 100 µg and placebo with hemodynamic response as a primary outcome measure.

Condition or disease Intervention/treatment Phase
Effects of; Anesthesia, in Pregnancy Drug: carbetocin 100 µg Drug: oxytocin 5 u Drug: placebo (NaCl) Phase 4

Detailed Description:
Healthy pregnant women sheduled for elective cesarean section. Invasive hemodynmaic monitoring with LiDCO Plus.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hemodynamic Effects of Carbetocin 100 µg, Oxytocin 5 U or Placebo After Cesarean Delivery Under Spinal Anesthesia in Healthy Pregnant Women.
Study Start Date : November 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arms and Interventions
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Arm Intervention/treatment
Experimental: carbetocin 100 µg
Carbetocin injection, 100µg, single injection
 Drug: carbetocin 100 µg
Hemodynamic effect of
Other Name: Pabal, injection
Active Comparator: oxytocin 5 u
Oxytocin 5U, injection, single injection
 Drug: oxytocin 5 u
Hemodynamic effect of
Other Name: Syntocinon, injection
Placebo Comparator: placebo (NaCl)
Saline single injection
 Drug: placebo (NaCl)
Hemodynamic effect of
Other Name: Saline, injection


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Bleeding [ Time Frame: 120 minutes ]
    The calculated estimated blood loss from delivery until 2 h after intervention


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy pregnant women for planned cesarean section

Exclusion Criteria:

  • Bleeding disorders
  • Placenta disorders
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00977769


Locations
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Norway
Division of Anaesthesia and Intensive Care Medicine, Oslo University Hospital - Rikshospitalet
Oslo, Norway, 0027
Division of Anesthesia and Intensive Care Medicine
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Leiv Arne Rosseland, MD PhD Oslo University Hospital
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Leiv Arne Rosseland, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00977769    
Other Study ID Numbers: 2009carb
First Posted: September 16, 2009    Key Record Dates
Results First Posted: May 6, 2014
Last Update Posted: May 6, 2014
Last Verified: April 2014
Keywords provided by Leiv Arne Rosseland, Oslo University Hospital:
cesarean delivery
blood pressure
cardiac output
Additional relevant MeSH terms:
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Oxytocin
Carbetocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs