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Carbetocin Versus Oxytocin and Hemodynamic Effects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 Type Interventional
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Carbetocin 100 µg Oxytocin 5 u Placebo (NaCl)
Hide Arm/Group Description 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
Arm/Group Title Carbetocin 100 µg Oxytocin 5 u Placebo (NaCl) Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 26 participants 25 participants 76 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
 100.0%
26
 100.0%
25
 100.0%
76
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 25 participants 26 participants 25 participants 76 participants
Female
25
 100.0%
26
 100.0%
25
 100.0%
76
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Norway Number Analyzed 25 participants 26 participants 25 participants 76 participants
25 26 25 76
1.Primary Outcome
Title Cardiac Output
Hide Description The relative change in CO from baseline at the time of delivery up to 2.5 minutes post delivery.
Time Frame 2.5 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carbetocin 100 µg Oxytocin 5 u Placebo (NaCl)
Hide Arm/Group Description:
carbetocin 100 µg : Hemodynamic effect of
oxytocin 5 u : Hemodynamic effect of
placebo (NaCl) : Hemodynamic effect of
Overall Number of Participants Analyzed 25 26 25
Mean (95% Confidence Interval)
Unit of Measure: percentage change in cardiac output
96
(80 to 111)
82
(64 to 100)
43
(35 to 51)
2.Primary Outcome
Title Arterial Blood Pressure
Hide Description The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery.
Time Frame 2.5 min
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carbetocin 100 µg Oxytocin 5 u Placebo (NaCl)
Hide Arm/Group Description:
carbetocin 100 µg : Hemodynamic effect of
oxytocin 5 u : Hemodynamic effect of
placebo (NaCl) : Hemodynamic effect of
Overall Number of Participants Analyzed 25 26 25
Mean (95% Confidence Interval)
Unit of Measure: percentage change in arterial blood pres
26
(20 to 31)
28
(22 to 34)
16
(9 to 22)
3.Secondary Outcome
Title Bleeding
Hide Description The calculated estimated blood loss from delivery until 2 h after intervention
Time Frame 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carbetocin 100 µg Oxytocin 5 u Placebo (NaCl)
Hide Arm/Group Description:
carbetocin 100 µg : Hemodynamic effect of
oxytocin 5 u : Hemodynamic effect of
placebo (NaCl) : Hemodynamic effect of
Overall Number of Participants Analyzed 25 26 25
Mean (Standard Deviation)
Unit of Measure: ml blood loss
579  (623) 841  (556) 853  (518)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Carbetocin 100 µg Oxytocin 5 u Placebo (NaCl)
Hide Arm/Group Description carbetocin 100 µg : Hemodynamic effect of oxytocin 5 u : Hemodynamic effect of placebo (NaCl) : Hemodynamic effect of
All-Cause Mortality
Carbetocin 100 µg Oxytocin 5 u Placebo (NaCl)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Carbetocin 100 µg Oxytocin 5 u Placebo (NaCl)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/26 (0.00%)      0/25 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Carbetocin 100 µg Oxytocin 5 u Placebo (NaCl)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/25 (36.00%)      9/26 (34.62%)      2/25 (8.00%)    
Cardiac disorders       
Chest pain  2/25 (8.00%)  2 2/26 (7.69%)  2 2/25 (8.00%)  2
Palpitations  0/25 (0.00%)  0 3/26 (11.54%)  3 0/25 (0.00%)  0
Gastrointestinal disorders       
Xerostomia  1/25 (4.00%)  1 0/26 (0.00%)  0 0/25 (0.00%)  0
Nervous system disorders       
Headache  2/25 (8.00%)  2 3/26 (11.54%)  3 0/25 (0.00%)  0
Metallic taste  0/25 (0.00%)  0 1/26 (3.85%)  1 0/25 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Shortness of breath  1/25 (4.00%)  1 0/26 (0.00%)  0 0/25 (0.00%)  0
Skin and subcutaneous tissue disorders       
Feeling of warmth  2/25 (8.00%)  2 2/26 (7.69%)  2 2/25 (8.00%)  2
Flushing  0/25 (0.00%)  0 2/26 (7.69%)  2 1/25 (4.00%)  1
Nasal congestion  1/25 (4.00%)  1 1/26 (3.85%)  1 0/25 (0.00%)  0
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Leiv Arne Rosseland
Organization: Oslo University Hospital
Phone: +4723070000
EMail: lrossela@ous-hf.no
Publications of Results:
Rosseland LA, Hauge TH, Grindheim G, Stubhaug A, Langesæter E. Changes in blood pressure and cardiac output during cesarean delivery: the effects of oxytocin and carbetocin compared with placebo. Anesthesiology. 2013 Sep;119(3):541-51. doi: 10.1097/ALN.0b013e31829416dd.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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