Trial Outcomes & Findings for Carbetocin Myocardium Trial 2014 Part 2 (NCT NCT03899961)

NCT ID: NCT03899961

Last Updated: 2026-02-10

Results Overview

Group difference in plasma concentration of Troponin I

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 240 participants
• Primary outcome timeframe: 8 hours
• Results posted on: 2026-02-10

Participant Flow

Participant milestones

Measure	Oxytocin Oxytocin 2.5 U i.v. Oxytocin: Oxytocin 2.5 U i.v.	Carbetocin Carbetocin 100 µg i.v. Carbetocin: Carbetocin 100 µg i.v.
Overall Study STARTED	121	119
Overall Study COMPLETED	112	103
Overall Study NOT COMPLETED	9	16

Reasons for withdrawal

Measure	Oxytocin Oxytocin 2.5 U i.v. Oxytocin: Oxytocin 2.5 U i.v.	Carbetocin Carbetocin 100 µg i.v. Carbetocin: Carbetocin 100 µg i.v.
Overall Study -delivery prior to	2	7
Overall Study req general anesth	1	2
Overall Study capacity	5	6
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Carbetocin Myocardium Trial 2014 Part 2

Baseline characteristics by cohort

Measure	Oxytocin n=112 Participants Oxytocin 2.5 U i.v. Oxytocin: Oxytocin 2.5 U i.v.	Carbetocin n=103 Participants Carbetocin 100 µg i.v. Carbetocin: Carbetocin 100 µg i.v.	Total n=215 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	112 Participants n=4 Participants	103 Participants n=4 Participants	215 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Age, Continuous	34.5 years n=4 Participants	35.0 years n=4 Participants	34.8 years n=8 Participants
Sex: Female, Male Female	112 Participants n=4 Participants	103 Participants n=4 Participants	215 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	112 Participants n=4 Participants	103 Participants n=4 Participants	215 Participants n=8 Participants
Region of Enrollment Norway	112 Participants n=4 Participants	103 Participants n=4 Participants	215 Participants n=8 Participants
Troponin I	1.0 ng/L n=4 Participants	1.0 ng/L n=4 Participants	1.0 ng/L n=8 Participants

PRIMARY outcome

Timeframe: 8 hours

Population: Biobank sample

Group difference in plasma concentration of Troponin I

Outcome measures

Measure	Oxytocin n=109 Participants Oxytocin 2.5 U i.v. Oxytocin: Oxytocin 2.5 U i.v.	Carbetocin n=99 Participants Carbetocin 100 µg i.v. Carbetocin: Carbetocin 100 µg i.v.
Plasma Concentration Troponin I	1.2 ng/L Interval 1.0 to 47.0	1.2 ng/L Interval 1.0 to 19.5

SECONDARY outcome

Timeframe: 10 hours

Blood loss estimated by hemoglobin

Outcome measures

Measure	Oxytocin n=112 Participants Oxytocin 2.5 U i.v. Oxytocin: Oxytocin 2.5 U i.v.	Carbetocin n=103 Participants Carbetocin 100 µg i.v. Carbetocin: Carbetocin 100 µg i.v.
Blood Loss	386 mL Standard Deviation 369	361 mL Standard Deviation 435

SECONDARY outcome

Timeframe: 5 min

Peroperative assessment of uterine tone grade 0-10 where 0 is no tonus, 10 is maximal tonus

Outcome measures

Measure	Oxytocin n=112 Participants Oxytocin 2.5 U i.v. Oxytocin: Oxytocin 2.5 U i.v.	Carbetocin n=103 Participants Carbetocin 100 µg i.v. Carbetocin: Carbetocin 100 µg i.v.
Uterine Tone Grade	7 score on a scale Interval 4.0 to 10.0	8 score on a scale Interval 4.0 to 10.0

SECONDARY outcome

Timeframe: 10 min

Population: Side effects in the time period 5 to 10 minutes

Perioperative side effects, such as palpitations

Outcome measures

Measure	Oxytocin n=112 Participants Oxytocin 2.5 U i.v. Oxytocin: Oxytocin 2.5 U i.v.	Carbetocin n=103 Participants Carbetocin 100 µg i.v. Carbetocin: Carbetocin 100 µg i.v.
Side Effects	50 Participants	55 Participants

Adverse Events

Oxytocin

Serious events: 0 serious events

Other events: 50 other events

Deaths: 0 deaths

Carbetocin

Serious events: 0 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Oxytocin n=112 participants at risk Oxytocin 2.5 U i.v. Oxytocin: Oxytocin 2.5 U i.v.	Carbetocin n=103 participants at risk Carbetocin 100 µg i.v. Carbetocin: Carbetocin 100 µg i.v.
General disorders Feeling hot	20.5% 23/112 • Number of events 23 • 48 h MedDRA v4	26.2% 27/103 • Number of events 27 • 48 h MedDRA v4
Cardiac disorders Chest pain	10.7% 12/112 • Number of events 12 • 48 h MedDRA v4	3.9% 4/103 • Number of events 4 • 48 h MedDRA v4
Respiratory, thoracic and mediastinal disorders dyspnoea	5.4% 6/112 • Number of events 6 • 48 h MedDRA v4	8.7% 9/103 • Number of events 9 • 48 h MedDRA v4
Cardiac disorders palpitations	6.2% 7/112 • Number of events 7 • 48 h MedDRA v4	2.9% 3/103 • Number of events 3 • 48 h MedDRA v4
Vascular disorders flushing	9.8% 11/112 • Number of events 11 • 48 h MedDRA v4	7.8% 8/103 • Number of events 8 • 48 h MedDRA v4
Nervous system disorders headache	5.4% 6/112 • Number of events 6 • 48 h MedDRA v4	7.8% 8/103 • Number of events 8 • 48 h MedDRA v4
Gastrointestinal disorders dry mouth	0.89% 1/112 • Number of events 1 • 48 h MedDRA v4	13.6% 14/103 • Number of events 14 • 48 h MedDRA v4
Gastrointestinal disorders nausea	7.1% 8/112 • Number of events 8 • 48 h MedDRA v4	9.7% 10/103 • Number of events 10 • 48 h MedDRA v4

Additional Information

Leiv Arne Rosseland

Oslo University Hospital

Phone: 92204274

Email: lrossela@ous-hf.no

Results disclosure agreements

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