Trial Outcomes & Findings for Carbetocin Versus Oxytocin and Hemodynamic Effects (NCT NCT00977769)

NCT ID: NCT00977769

Last Updated: 2014-05-06

Results Overview

The relative change in CO from baseline at the time of delivery up to 2.5 minutes post delivery.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 76 participants
• Primary outcome timeframe: 2.5 minutes
• Results posted on: 2014-05-06

Participant Flow

Participant milestones

Measure	Carbetocin 100 µg carbetocin 100 µg : Hemodynamic effect of	Oxytocin 5 u oxytocin 5 u : Hemodynamic effect of	Placebo (NaCl) placebo (NaCl) : Hemodynamic effect of
Overall Study STARTED	25	26	25
Overall Study COMPLETED	25	26	25
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Carbetocin Versus Oxytocin and Hemodynamic Effects

Baseline characteristics by cohort

Measure	Carbetocin 100 µg n=25 Participants carbetocin 100 µg : Hemodynamic effect of	Oxytocin 5 u n=26 Participants oxytocin 5 u : Hemodynamic effect of	Placebo (NaCl) n=25 Participants placebo (NaCl) : Hemodynamic effect of	Total n=76 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	26 Participants n=7 Participants	25 Participants n=5 Participants	76 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	34.2 years STANDARD_DEVIATION 3.8 • n=5 Participants	35.0 years STANDARD_DEVIATION 5.0 • n=7 Participants	34.8 years STANDARD_DEVIATION 4.0 • n=5 Participants	34.5 years STANDARD_DEVIATION 4.6 • n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	26 Participants n=7 Participants	25 Participants n=5 Participants	76 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Norway	25 participants n=5 Participants	26 participants n=7 Participants	25 participants n=5 Participants	76 participants n=4 Participants

PRIMARY outcome

Timeframe: 2.5 minutes

The relative change in CO from baseline at the time of delivery up to 2.5 minutes post delivery.

Outcome measures

Measure	Carbetocin 100 µg n=25 Participants carbetocin 100 µg : Hemodynamic effect of	Oxytocin 5 u n=26 Participants oxytocin 5 u : Hemodynamic effect of	Placebo (NaCl) n=25 Participants placebo (NaCl) : Hemodynamic effect of
Cardiac Output	96 percentage change in cardiac output Interval 80.0 to 111.0	82 percentage change in cardiac output Interval 64.0 to 100.0	43 percentage change in cardiac output Interval 35.0 to 51.0

PRIMARY outcome

Timeframe: 2.5 min

The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery.

Outcome measures

Measure	Carbetocin 100 µg n=25 Participants carbetocin 100 µg : Hemodynamic effect of	Oxytocin 5 u n=26 Participants oxytocin 5 u : Hemodynamic effect of	Placebo (NaCl) n=25 Participants placebo (NaCl) : Hemodynamic effect of
Arterial Blood Pressure	26 percentage change in arterial blood pres Interval 20.0 to 31.0	28 percentage change in arterial blood pres Interval 22.0 to 34.0	16 percentage change in arterial blood pres Interval 9.0 to 22.0

SECONDARY outcome

Timeframe: 120 minutes

The calculated estimated blood loss from delivery until 2 h after intervention

Outcome measures

Measure	Carbetocin 100 µg n=25 Participants carbetocin 100 µg : Hemodynamic effect of	Oxytocin 5 u n=26 Participants oxytocin 5 u : Hemodynamic effect of	Placebo (NaCl) n=25 Participants placebo (NaCl) : Hemodynamic effect of
Bleeding	579 ml blood loss Standard Deviation 623	841 ml blood loss Standard Deviation 556	853 ml blood loss Standard Deviation 518

Adverse Events

Carbetocin 100 µg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Oxytocin 5 u

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo (NaCl)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Carbetocin 100 µg n=25 participants at risk carbetocin 100 µg : Hemodynamic effect of	Oxytocin 5 u n=26 participants at risk oxytocin 5 u : Hemodynamic effect of	Placebo (NaCl) n=25 participants at risk placebo (NaCl) : Hemodynamic effect of
Skin and subcutaneous tissue disorders Feeling of warmth	8.0% 2/25 • Number of events 2	7.7% 2/26 • Number of events 2	8.0% 2/25 • Number of events 2
Cardiac disorders Chest pain	8.0% 2/25 • Number of events 2	7.7% 2/26 • Number of events 2	8.0% 2/25 • Number of events 2
Respiratory, thoracic and mediastinal disorders Shortness of breath	4.0% 1/25 • Number of events 1	0.00% 0/26	0.00% 0/25
Cardiac disorders Palpitations	0.00% 0/25	11.5% 3/26 • Number of events 3	0.00% 0/25
Skin and subcutaneous tissue disorders Flushing	0.00% 0/25	7.7% 2/26 • Number of events 2	4.0% 1/25 • Number of events 1
Nervous system disorders Headache	8.0% 2/25 • Number of events 2	11.5% 3/26 • Number of events 3	0.00% 0/25
Skin and subcutaneous tissue disorders Nasal congestion	4.0% 1/25 • Number of events 1	3.8% 1/26 • Number of events 1	0.00% 0/25
Gastrointestinal disorders Xerostomia	4.0% 1/25 • Number of events 1	0.00% 0/26	0.00% 0/25
Nervous system disorders Metallic taste	0.00% 0/25	3.8% 1/26 • Number of events 1	0.00% 0/25

Additional Information

Professor Leiv Arne Rosseland

Oslo University Hospital

Phone: +4723070000

Email: lrossela@ous-hf.no

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place