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

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01382732
• Other study ID #: MHST2011-06
• Status: Recruiting
• Phase: Phase 3
• First received: June 24, 2011
• Last updated: January 1, 2015
• Start date: January 2012
• Est. completion date: January 2016

Study information

• Verified date: January 2015
• Source: Saint Thomas Hospital, Panama
• Contact: n/a
• Is FDA regulated: No
• Health authority: Panama: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 636
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant women between 28 weeks and term

• Severe pre-eclampsia

Exclusion Criteria:

• Twin pregnancy

• Coagulation disorders

• HELLP Syndrome

• Eclampsia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage
• Pre-Eclampsia
• Severe Preeclampsia

Intervention

Drug:
• Carbetocin
Protocol A (carbetocin + placebo) Carbetocin: 100ug (1mL) + Ringer's Lactate 10mL directly into the vein in no less than two minutes.
• 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

Locations

Country	Name	City	State
Panama	Saint Thomas H	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for additional uterotonics	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.	Six months	No
Secondary	Development of oliguria	Number of cases that develop oliguria (<30 mL/hr over a 2 hour period) after the administration of the drug.	six months	No
Secondary	Changes in hemodynamic status	Changes in Systolic pressure , dyastolic pressure, mean arterial pressure and heart rate one and two hours after the administration of the drug.	six months	Yes