drugset / Trial / NCT01382732

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

NCT01382732

Phase 3 Unknown 636 enrolled Saint Thomas Hospital, Panama
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2012-01
Primary completion
2015-12
Completion
2016-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Carbetocin Peptide 100 ug Intravenous
Comparator Oxytocin Peptide 20 iu Intravenous

Indications