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

Phase 3

• Conditions: Severe Preeclampsia; Postpartum Hemorrhage
• Interventions: Drug: Carbetocin; Drug: Oxytocin

• Registration Number: NCT01382732
• Lead Sponsor: Saint Thomas Hospital, Panama

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-24
• Study First Submitted QC: 2011-06-24
• Study First Posted: 2011-06-27
• Study Start: 2012-01
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-01
• Last Update Posted: 2015-01-05
• Primary Completion: 2015-12
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 636

Inclusion Criteria

• Pregnant women between 28 weeks and term
• Severe pre-eclampsia

Exclusion Criteria

• Twin pregnancy
• Coagulation disorders
• HELLP Syndrome
• Eclampsia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbetocin	Carbetocin	Protocol A (carbetocin + placebo) Carbetocin: 100ug (1mL) + Ringer's Lactate 10mL directly into the vein in no less than two minutes. Ringer's Lactate 4mL applied to a bag with 1000mL of Ringer's Lactate to be passed intravenously at a rate of 125mL/hr
Oxytocin	Oxytocin	Protocol B (oxytocin + placebo) Ringer's Lactate 11mL directly into the vein in no less than two minutes. Oxytocin 20 U (4mL) diluted in a bag with 1000mL of Ringer's Lactate to be passed intravenously at a rate of 125mL/hr

Primary Outcome Measures

Name	Time	Method
Need for additional uterotonics	Six months	Number of cases allocated to one arm of the study that due to the presence of continous bleeding postpartum need the use of an additional uterotonic.

Secondary Outcome Measures

Name	Time	Method
Development of oliguria	six months	Number of cases that develop oliguria (\<30 mL/hr over a 2 hour period) after the administration of the drug.
Changes in hemodynamic status	six months	Changes in Systolic pressure , dyastolic pressure, mean arterial pressure and heart rate one and two hours after the administration of the drug.

Trial Locations

Locations (1)

Saint Thomas H; 🇵🇦 Panama, Panama