Carbetocin Versus Oxytocin and Hemodynamic Effects

This study has been completed.
Sponsor:
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
  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 April 17, 2014