Trial Outcomes & Findings for Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study (NCT NCT03716076)
NCT ID: NCT03716076
Last Updated: 2021-05-14
Results Overview
Time interval between peak and end of T-wave (Tp-e)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
5 minutes post-carbetocin administration
Results posted on
2021-05-14
Participant Flow
Participant milestones
| Measure |
Participant Receives 50 mcg of Carbetocin Post-delivery.
Participant receives 50 mcg of carbetocin post-delivery.
Carbetocin: 50 mcg or 100 mcg bolus of carbetocin
|
Participant Receives 100 mcg of Carbetocin Post-delivery.
Participant receives 100 mcg of carbetocin post-delivery.
Carbetocin: 50 mcg or 100 mcg bolus of carbetocin
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
22
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Participant Receives 50 mcg of Carbetocin Post-delivery.
n=22 Participants
Participant receives 50 mcg of carbetocin post-delivery.
Carbetocin: 50 mcg or 100 mcg bolus of carbetocin
|
Participant Receives 100 mcg of Carbetocin Post-delivery.
n=19 Participants
Participant receives 100 mcg of carbetocin post-delivery.
Carbetocin: 50 mcg or 100 mcg bolus of carbetocin
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 4.3 • n=22 Participants
|
35.7 years
STANDARD_DEVIATION 2.8 • n=19 Participants
|
35 years
STANDARD_DEVIATION 3.7 • n=41 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=22 Participants
|
19 Participants
n=19 Participants
|
41 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=22 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=41 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
22 participants
n=22 Participants
|
19 participants
n=19 Participants
|
41 participants
n=41 Participants
|
|
Mean Arterial Pressure
|
89.7 mmHg
STANDARD_DEVIATION 10.4 • n=22 Participants
|
88.5 mmHg
STANDARD_DEVIATION 8.3 • n=19 Participants
|
89.2 mmHg
STANDARD_DEVIATION 9.4 • n=41 Participants
|
|
Heart Rate
|
83.0 bpm
STANDARD_DEVIATION 8.6 • n=22 Participants
|
81.8 bpm
STANDARD_DEVIATION 9.0 • n=19 Participants
|
82.0 bpm
STANDARD_DEVIATION 8.7 • n=41 Participants
|
|
Gravida
|
2 pregnancies
n=22 Participants
|
2 pregnancies
n=19 Participants
|
2 pregnancies
n=41 Participants
|
|
Parity of 0
|
7 participants
n=22 Participants
|
5 participants
n=19 Participants
|
12 participants
n=41 Participants
|
|
Gestational Age
|
38.9 weeks
STANDARD_DEVIATION 0.8 • n=22 Participants
|
39.2 weeks
STANDARD_DEVIATION 0.5 • n=19 Participants
|
39.0 weeks
STANDARD_DEVIATION 0.7 • n=41 Participants
|
|
Parity greater than 0
|
15 participants
n=22 Participants
|
14 participants
n=19 Participants
|
29 participants
n=41 Participants
|
|
Baseline QTc
|
413.7 milliseconds
STANDARD_DEVIATION 11.0 • n=22 Participants
|
409.0 milliseconds
STANDARD_DEVIATION 15.8 • n=19 Participants
|
411.6 milliseconds
STANDARD_DEVIATION 13.5 • n=41 Participants
|
|
Baseline Tp-e
|
67.5 milliseconds
STANDARD_DEVIATION 8.2 • n=22 Participants
|
69.6 milliseconds
STANDARD_DEVIATION 5.7 • n=19 Participants
|
68.5 milliseconds
STANDARD_DEVIATION 7.1 • n=41 Participants
|
|
Weight
|
74.9 Kilograms
STANDARD_DEVIATION 13.2 • n=22 Participants
|
75.1 Kilograms
STANDARD_DEVIATION 10.7 • n=19 Participants
|
75.0 Kilograms
STANDARD_DEVIATION 12.0 • n=41 Participants
|
|
Phenylephrine Dose
|
1459.0 micrograms
STANDARD_DEVIATION 426.1 • n=22 Participants
|
1538.1 micrograms
STANDARD_DEVIATION 479.2 • n=19 Participants
|
1495.6 micrograms
STANDARD_DEVIATION 500.2 • n=41 Participants
|
PRIMARY outcome
Timeframe: 5 minutes post-carbetocin administrationTime interval between peak and end of T-wave (Tp-e)
Outcome measures
| Measure |
Participant Receives 50 mcg of Carbetocin Post-delivery.
n=22 Participants
Participant receives 50 mcg of carbetocin post-delivery.
Carbetocin: 50 mcg or 100 mcg bolus of carbetocin
|
Participant Receives 100 mcg of Carbetocin Post-delivery.
n=19 Participants
Participant receives 100 mcg of carbetocin post-delivery.
Carbetocin: 50 mcg or 100 mcg bolus of carbetocin
|
|---|---|---|
|
Tp-e
|
69.5 milliseconds
Standard Deviation 7.7
|
74.7 milliseconds
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: perioperatively, typically ranging 30 minutes-1 hourOccurrence of Atrial or Ventricular Arrhythmias
Outcome measures
| Measure |
Participant Receives 50 mcg of Carbetocin Post-delivery.
n=22 Participants
Participant receives 50 mcg of carbetocin post-delivery.
Carbetocin: 50 mcg or 100 mcg bolus of carbetocin
|
Participant Receives 100 mcg of Carbetocin Post-delivery.
n=19 Participants
Participant receives 100 mcg of carbetocin post-delivery.
Carbetocin: 50 mcg or 100 mcg bolus of carbetocin
|
|---|---|---|
|
Arrhythmia
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 min post-carbetocin administrationBazette corrected Q-T interval
Outcome measures
| Measure |
Participant Receives 50 mcg of Carbetocin Post-delivery.
n=22 Participants
Participant receives 50 mcg of carbetocin post-delivery.
Carbetocin: 50 mcg or 100 mcg bolus of carbetocin
|
Participant Receives 100 mcg of Carbetocin Post-delivery.
n=19 Participants
Participant receives 100 mcg of carbetocin post-delivery.
Carbetocin: 50 mcg or 100 mcg bolus of carbetocin
|
|---|---|---|
|
QTc at 5 Min
|
435.1 milliseconds
Standard Deviation 18.3
|
434.2 milliseconds
Standard Deviation 18.8
|
SECONDARY outcome
Timeframe: 10 minutes post-carbetocin administrationBazette corrected Q-T interval (QTc)
Outcome measures
| Measure |
Participant Receives 50 mcg of Carbetocin Post-delivery.
n=22 Participants
Participant receives 50 mcg of carbetocin post-delivery.
Carbetocin: 50 mcg or 100 mcg bolus of carbetocin
|
Participant Receives 100 mcg of Carbetocin Post-delivery.
n=19 Participants
Participant receives 100 mcg of carbetocin post-delivery.
Carbetocin: 50 mcg or 100 mcg bolus of carbetocin
|
|---|---|---|
|
QTc 10 Min
|
431.6 milliseconds
Standard Deviation 18.2
|
431.9 milliseconds
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: 5 min post-administration of spinal anesthesiaBazette corrected Q-T interval change after spinal anesthesia
Outcome measures
| Measure |
Participant Receives 50 mcg of Carbetocin Post-delivery.
n=22 Participants
Participant receives 50 mcg of carbetocin post-delivery.
Carbetocin: 50 mcg or 100 mcg bolus of carbetocin
|
Participant Receives 100 mcg of Carbetocin Post-delivery.
n=19 Participants
Participant receives 100 mcg of carbetocin post-delivery.
Carbetocin: 50 mcg or 100 mcg bolus of carbetocin
|
|---|---|---|
|
QTc 5 Min Spinal
|
409.4 milliseconds
Standard Deviation 19.2
|
413.6 milliseconds
Standard Deviation 17.4
|
SECONDARY outcome
Timeframe: 5 minutes after administration of spinal anesthesiaTime between peak and end of T-wave,
Outcome measures
| Measure |
Participant Receives 50 mcg of Carbetocin Post-delivery.
n=22 Participants
Participant receives 50 mcg of carbetocin post-delivery.
Carbetocin: 50 mcg or 100 mcg bolus of carbetocin
|
Participant Receives 100 mcg of Carbetocin Post-delivery.
n=19 Participants
Participant receives 100 mcg of carbetocin post-delivery.
Carbetocin: 50 mcg or 100 mcg bolus of carbetocin
|
|---|---|---|
|
Tp-e 5 Min Post-spinal
|
69.5 milliseconds
Standard Deviation 8.6
|
70.9 milliseconds
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: 10 minutes post-carbetocin administrationTime between peak and end of T-wave
Outcome measures
| Measure |
Participant Receives 50 mcg of Carbetocin Post-delivery.
n=22 Participants
Participant receives 50 mcg of carbetocin post-delivery.
Carbetocin: 50 mcg or 100 mcg bolus of carbetocin
|
Participant Receives 100 mcg of Carbetocin Post-delivery.
n=19 Participants
Participant receives 100 mcg of carbetocin post-delivery.
Carbetocin: 50 mcg or 100 mcg bolus of carbetocin
|
|---|---|---|
|
Tp-e at 10 Min
|
69.4 milliseconds
Standard Deviation 8.2
|
71.8 milliseconds
Standard Deviation 5.5
|
Adverse Events
Participant Receives 50 mcg of Carbetocin Post-delivery.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Participant Receives 100 mcg of Carbetocin Post-delivery.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place