Carbetocin Versus Oxytocin and Hemodynamic Effects

Effects of; Anesthesia, in Pregnancy Clinical Trial

Official title:

Hemodynamic Effects of Carbetocin 100 µg, Oxytocin 5 U or Placebo After Cesarean Delivery Under Spinal Anesthesia in Healthy Pregnant Women.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00977769
• Other study ID #: 2009carb
• Status: Completed
• Phase: Phase 4
• First received: September 15, 2009
• Last updated: April 4, 2014
• Start date: November 2009
• Est. completion date: October 2011

Study information

• Verified date: April 2014
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

A randomized double-blind trial of oxytocin 5 u, carbetocin 100 µg and placebo with hemodynamic response as a primary outcome measure.

Description:

Healthy pregnant women sheduled for elective cesarean section. Invasive hemodynmaic monitoring with LiDCO Plus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: October 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy pregnant women for planned cesarean section

Exclusion Criteria:

• Bleeding disorders

• Placenta disorders

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Effects of; Anesthesia, in Pregnancy

Intervention

Drug:
• carbetocin 100 µg
Hemodynamic effect of
• oxytocin 5 u
Hemodynamic effect of
• placebo (NaCl)
Hemodynamic effect of

Locations

Country	Name	City	State
Norway	Division of Anaesthesia and Intensive Care Medicine, Oslo University Hospital - Rikshospitalet	Oslo
Norway	Division of Anesthesia and Intensive Care Medicine	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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.0b — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Output	The relative change in CO from baseline at the time of delivery up to 2.5 minutes post delivery.	2.5 minutes	Yes
Primary	Arterial Blood Pressure	The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery.	2.5 min	Yes
Secondary	Bleeding	The calculated estimated blood loss from delivery until 2 h after intervention	120 minutes	Yes