Carbetocin Versus Oxytocin and Hemodynamic Effects
This study has been completed.
Sponsor:
Oslo University Hospital
Information provided by (Responsible Party):
Leiv Arne Rosseland, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00977769
First received: September 15, 2009
Last updated: October 26, 2011
Last verified: October 2011
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Purpose
A randomized double-blind trial of oxytocin 5 u, carbetocin 100 µg and placebo with hemodynamic response as a primary outcome measure.
| Condition | Intervention | Phase |
|---|---|---|
|
Pregnancy, Anesthesia |
Drug: carbetocin 100 µg Drug: oxytocin 5 u Drug: placebo (NaCl) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Hemodynamiske Effekter av Carbetocin 100 µg, Oxytocin 5 IE og Placebo Hos Kvinner Som gjennomgår Keisersnitt i spinalbedøvelse |
Resource links provided by NLM:
Further study details as provided by Oslo University Hospital:
Primary Outcome Measures:
- Cardiac output [ Time Frame: 10 minutes ] [ Designated as safety issue: Yes ]
- Arterial blood pressure [ Time Frame: 10 min ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Peripheral vascular resistance [ Time Frame: 10 minutes ] [ Designated as safety issue: Yes ]
- Bleeding [ Time Frame: 120 minutes ] [ Designated as safety issue: Yes ]
| Enrollment: | 76 |
| Study Start Date: | November 2009 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: carbetocin 100 µg |
Drug: carbetocin 100 µg
Hemodynamic effect of
Other Name: Pabal
|
| Active Comparator: oxytocin 5 u |
Drug: oxytocin 5 u
Hemodynamic effect of
Other Name: Syntocinon
|
| Placebo Comparator: placebo (NaCl) |
Drug: placebo (NaCl)
Hemodynamic effect of
Other Name: Saline
|
Detailed Description:
Healthy pregnant women sheduled for elective cesarean section. Invasive hemodynmaic monitoring with LiDCO Plus.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Healthy pregnant women for planned cesarean section
Exclusion Criteria:
- Bleeding disorders
- Placenta disorders
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977769
Locations
| 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 | |
Sponsors and Collaborators
Oslo University Hospital
Investigators
| Principal Investigator: | Leiv Arne Rosseland, MD PhD | Oslo University Hospital - Rikshospitalet |
More Information
No publications provided
| Responsible Party: | Leiv Arne Rosseland, Professor, Oslo University Hospital |
| ClinicalTrials.gov Identifier: | NCT00977769 History of Changes |
| Other Study ID Numbers: | 2009carb |
| Study First Received: | September 15, 2009 |
| Last Updated: | October 26, 2011 |
| Health Authority: | Norway: Norwegian Medicines Agency |
Keywords provided by Oslo University Hospital:
|
cesarean delivery blood pressure cardiac output |
Additional relevant MeSH terms:
|
Oxytocin Carbetocin Oxytocics Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013