Carbetocin Versus Oxytocin and Hemodynamic Effects

University of Oslo (UIO)

Status and phase: Completed; Phase 4

Conditions: Effects of; Anesthesia, in Pregnancy

Treatments: Drug: carbetocin 100 µg; Drug: placebo (NaCl); Drug: oxytocin 5 u

Study type: Interventional

Funder types: Other

Identifiers

NCT00977769

2009carb

Details and patient eligibility

About

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

Full description

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

Enrollment: 76 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy pregnant women for planned cesarean section

Exclusion criteria

• Bleeding disorders
• Placenta disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

76 participants in 3 patient groups, including a placebo group

carbetocin 100 µg

Experimental group

Description:

Carbetocin injection, 100µg, single injection

Treatment:

Drug: carbetocin 100 µg

oxytocin 5 u

Active Comparator group

Description:

Oxytocin 5U, injection, single injection

Treatment:

Drug: oxytocin 5 u

placebo (NaCl)

Placebo Comparator group

Description:

Saline single injection

Treatment:

Drug: placebo (NaCl)