Carbetocin Versus Oxytocin and Hemodynamic Effects

• ClinicalTrials.gov Identifier: NCT00977769
• Recruitment Status: Completed
• First Posted: September 16, 2009
• Results First Posted: May 6, 2014
• Last Update Posted: May 6, 2014
• Sponsor: Oslo University Hospital
• Information provided by (Responsible Party): Leiv Arne Rosseland, Oslo University Hospital

Tracking Information

• First Submitted Date: September 15, 2009
• First Posted Date: September 16, 2009
• Results First Submitted Date: April 24, 2013
• Results First Posted Date: May 6, 2014
• Last Update Posted Date: May 6, 2014
• Study Start Date: November 2009
• Actual Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 4, 2014)

• 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.

• Original Primary Outcome Measures (submitted: September 15, 2009): Cardiac output [ Time Frame: 10 minutes ]

Current Secondary Outcome Measures (submitted: April 4, 2014)

Bleeding [ Time Frame: 120 minutes ]

The calculated estimated blood loss from delivery until 2 h after intervention

Original Secondary Outcome Measures (submitted: September 15, 2009)

• Blood pressure [ Time Frame: 30 minutes ]
• Peripheral vascular resistance [ Time Frame: 30 minutes ]
• Bleeding [ Time Frame: 30 minutes ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Carbetocin Versus Oxytocin and Hemodynamic Effects
• Official Title: Hemodynamic Effects of Carbetocin 100 µg, Oxytocin 5 U or Placebo After Cesarean Delivery Under Spinal Anesthesia in Healthy Pregnant Women.
• 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Effects of; Anesthesia, in Pregnancy

Intervention

• Drug: carbetocin 100 µg
  Hemodynamic effect of
  Other Name: Pabal, injection
• Drug: oxytocin 5 u
  Hemodynamic effect of
  Other Name: Syntocinon, injection
• Drug: placebo (NaCl)
  Hemodynamic effect of
  Other Name: Saline, injection

Study Arms

• Experimental: carbetocin 100 µg
  Carbetocin injection, 100µg, single injection
  Intervention: Drug: carbetocin 100 µg
• Active Comparator: oxytocin 5 u
  Oxytocin 5U, injection, single injection
  Intervention: Drug: oxytocin 5 u
• Placebo Comparator: placebo (NaCl)
  Saline single injection
  Intervention: Drug: placebo (NaCl)

Publications *

• Rosseland LA, Hauge TH, Grindheim G, Stubhaug A, Langesæter E. Changes in blood pressure and cardiac output during cesarean delivery: the effects of oxytocin and carbetocin compared with placebo. Anesthesiology. 2013 Sep;119(3):541-51. doi: 10.1097/ALN.0b013e31829416dd.
• Michelsen TM, Tronstad C, Rosseland LA. Blood pressure and cardiac output during caesarean delivery under spinal anaesthesia: a prospective cohort study. BMJ Open. 2021 Jun 14;11(6):e046102. doi: 10.1136/bmjopen-2020-046102.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 26, 2011): 76
• Original Estimated Enrollment (submitted: September 15, 2009): 75
• Actual Study Completion Date: October 2011
• Actual Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Healthy pregnant women for planned cesarean section

Exclusion Criteria:

• Bleeding disorders
• Placenta disorders

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Norway

Administrative Information

• NCT Number: NCT00977769
• Other Study ID Numbers: 2009carb
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Leiv Arne Rosseland, Oslo University Hospital
• Study Sponsor: Oslo University Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Leiv Arne Rosseland, MD PhD; Oslo University Hospital

• PRS Account: Oslo University Hospital
• Verification Date: April 2014