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: April 4, 2014
Last verified: April 2014
  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
Effects of; Anesthesia, in Pregnancy
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: Hemodynamic Effects of Carbetocin 100 µg, Oxytocin 5 U or Placebo After Cesarean Delivery Under Spinal Anesthesia in Healthy Pregnant Women.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Cardiac Output [ Time Frame: 2.5 minutes ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery.


Secondary Outcome Measures:
  • Bleeding [ Time Frame: 120 minutes ] [ Designated as safety issue: Yes ]
    The calculated estimated blood loss from delivery until 2 h after intervention


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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
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
Results First Received: April 24, 2013
Last Updated: April 4, 2014
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 September 14, 2014