Effects of; Anesthesia, in Pregnancy
Conditions
Keywords
cesarean delivery, blood pressure, cardiac output
Brief summary
A randomized double-blind trial of oxytocin 5 u, carbetocin 100 µg and placebo with hemodynamic response as a primary outcome measure.
Detailed description
Healthy pregnant women sheduled for elective cesarean section. Invasive hemodynmaic monitoring with LiDCO Plus.
Interventions
DRUGoxytocin 5 u
Hemodynamic effect of
DRUGplacebo (NaCl)
Hemodynamic effect of
DRUGcarbetocin 100 µg
Hemodynamic effect of
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Healthy pregnant women for planned cesarean section
Exclusion criteria
* Bleeding disorders * Placenta disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Output | 2.5 minutes | The relative change in CO from baseline at the time of delivery up to 2.5 minutes post delivery. |
| Arterial Blood Pressure | 2.5 min | The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding | 120 minutes | The calculated estimated blood loss from delivery until 2 h after intervention |
Countries
Norway
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Carbetocin 100 µg carbetocin 100 µg : Hemodynamic effect of | 25 |
| Oxytocin 5 u oxytocin 5 u : Hemodynamic effect of | 26 |
| Placebo (NaCl) placebo (NaCl) : Hemodynamic effect of | 25 |
| Total | 76 |
Baseline characteristics
| Characteristic | Oxytocin 5 u | Placebo (NaCl) | Carbetocin 100 µg | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 25 Participants | 25 Participants | 76 Participants |
| Age, Continuous | 35.0 years STANDARD_DEVIATION 5 | 34.8 years STANDARD_DEVIATION 4 | 34.2 years STANDARD_DEVIATION 3.8 | 34.5 years STANDARD_DEVIATION 4.6 |
| Region of Enrollment Norway | 26 participants | 25 participants | 25 participants | 76 participants |
| Sex: Female, Male Female | 26 Participants | 25 Participants | 25 Participants | 76 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 25 | 9 / 26 | 2 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 26 | 0 / 25 |
Outcome results
Primary
Arterial Blood Pressure
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Carbetocin 100 µg | Arterial Blood Pressure | 26 percentage change in arterial blood pres |
| Oxytocin 5 u | Arterial Blood Pressure | 28 percentage change in arterial blood pres |
| Placebo (NaCl) | Arterial Blood Pressure | 16 percentage change in arterial blood pres |
Primary
Cardiac Output
The relative change in CO from baseline at the time of delivery up to 2.5 minutes post delivery.
Time frame: 2.5 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Carbetocin 100 µg | Cardiac Output | 96 percentage change in cardiac output |
| Oxytocin 5 u | Cardiac Output | 82 percentage change in cardiac output |
| Placebo (NaCl) | Cardiac Output | 43 percentage change in cardiac output |
Secondary
Bleeding
The calculated estimated blood loss from delivery until 2 h after intervention
Time frame: 120 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Carbetocin 100 µg | Bleeding | 579 ml blood loss | Standard Deviation 623 |
| Oxytocin 5 u | Bleeding | 841 ml blood loss | Standard Deviation 556 |
| Placebo (NaCl) | Bleeding | 853 ml blood loss | Standard Deviation 518 |