NCT01382732

Carbetocin vs. Oxytocin for Prevention of Postpartum Bleeding in Patients With Severe Preeclampsia

Carbetocin Versus Oxytocin for Prevention of Postpartum Hemorrhage in Patients With Severe Preeclampsia: a Double Blind Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 636 (estimated)
• Sponsor: Saint Thomas Hospital, Panama · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

Postpartum hemorrhage is an important cause of maternal morbidity and mortality. In patients with severe preeclampsia there is an increased risk of postpartum hemorrhage but the hemodynamic changes associated with this pathology make the management of any kind of bleeding particularly troublesome. There are many pharmacological options, being oxytocin the first line of treatment. However there is no evidence about the safety and efficacy of carbetocin, an oxytocin agonist. The investigators aimed to compare oxytocin with carbetocin for the routine prevention of postpartum hemorrhage in patients with severe preeclampsia.

Conditions

• Severe Preeclampsia
• Postpartum Hemorrhage

Interventions

Type	Name	Description
DRUG	Carbetocin	Protocol A (carbetocin + placebo) Carbetocin: 100ug (1mL) + Ringer's Lactate 10mL directly into the vein in no less than two minutes.
DRUG	Oxytocin	Oxytocin 20 U (4mL) diluted in a bag with 1000mL of Ringer's Lactate to be passed intravenously at a rate of 125mL/hr

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2011-06-27
• Last updated: 2015-01-05

Locations

1 site across 1 country: Panama