Carbetocin Versus Oxytocin and Hemodynamic Effects

Phase 4

Completed

• Conditions: Effects of; Anesthesia, in Pregnancy
• Interventions: Drug: carbetocin 100 µg; Drug: oxytocin 5 u; Drug: placebo (NaCl)

• Registration Number: NCT00977769
• Lead Sponsor: Oslo University Hospital

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 Timeline

• Study First Submitted: 2009-09-15
• Study First Submitted QC: 2009-09-15
• Study First Posted: 2009-09-16
• Study Start: 2009-11
• Primary Completion: 2011-08
• Study Completion: 2011-10
• Results First Submitted: 2013-04-24
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-04
• Last Update Submitted: 2014-04-04
• Results First Posted: 2014-05-06
• Last Update Posted: 2014-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

• Healthy pregnant women for planned cesarean section

Exclusion Criteria

• Bleeding disorders
• Placenta disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
carbetocin 100 µg	carbetocin 100 µg	Carbetocin injection, 100µg, single injection
oxytocin 5 u	oxytocin 5 u	Oxytocin 5U, injection, single injection
placebo (NaCl)	placebo (NaCl)	Saline single injection

Primary Outcome Measures

Name	Time	Method
Cardiac Output	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	2.5 min	The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery.

Secondary Outcome Measures

Name	Time	Method
Bleeding	120 minutes	The calculated estimated blood loss from delivery until 2 h after intervention

Trial Locations

Locations (2)

Division of Anesthesia and Intensive Care Medicine; 🇳🇴 Oslo, Norway

Division of Anaesthesia and Intensive Care Medicine, Oslo University Hospital - Rikshospitalet; 🇳🇴 Oslo, Norway