Carbetocin Versus Oxytocin and Hemodynamic Effects
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ClinicalTrials.gov Identifier: NCT00977769 |
Recruitment Status :
Completed
First Posted : September 16, 2009
Results First Posted : May 6, 2014
Last Update Posted : May 6, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Effects of; Anesthesia, in Pregnancy | Drug: carbetocin 100 µg Drug: oxytocin 5 u Drug: placebo (NaCl) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 76 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Hemodynamic Effects of Carbetocin 100 µg, Oxytocin 5 U or Placebo After Cesarean Delivery Under Spinal Anesthesia in Healthy Pregnant Women. |
Study Start Date : | November 2009 |
Actual Primary Completion Date : | August 2011 |
Actual Study Completion Date : | October 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: carbetocin 100 µg
Carbetocin injection, 100µg, single injection
|
Drug: carbetocin 100 µg
Hemodynamic effect of
Other Name: Pabal, injection |
Active Comparator: oxytocin 5 u
Oxytocin 5U, injection, single injection
|
Drug: oxytocin 5 u
Hemodynamic effect of
Other Name: Syntocinon, injection |
Placebo Comparator: placebo (NaCl)
Saline single injection
|
Drug: placebo (NaCl)
Hemodynamic effect of
Other Name: Saline, injection |
- Cardiac Output [ Time Frame: 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 [ Time Frame: 2.5 min ]The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery.
- Bleeding [ Time Frame: 120 minutes ]The calculated estimated blood loss from delivery until 2 h after intervention

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Healthy pregnant women for planned cesarean section
Exclusion Criteria:
- Bleeding disorders
- Placenta disorders

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00977769
Norway | |
Division of Anaesthesia and Intensive Care Medicine, Oslo University Hospital - Rikshospitalet | |
Oslo, Norway, 0027 | |
Division of Anesthesia and Intensive Care Medicine | |
Oslo, Norway, 0027 |
Principal Investigator: | Leiv Arne Rosseland, MD PhD | Oslo University Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Leiv Arne Rosseland, Professor, Oslo University Hospital |
ClinicalTrials.gov Identifier: | NCT00977769 |
Other Study ID Numbers: |
2009carb |
First Posted: | September 16, 2009 Key Record Dates |
Results First Posted: | May 6, 2014 |
Last Update Posted: | May 6, 2014 |
Last Verified: | April 2014 |
cesarean delivery blood pressure cardiac output |
Oxytocin Carbetocin Oxytocics Reproductive Control Agents Physiological Effects of Drugs |