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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Saint Thomas Hospital, Panama
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier:
NCT01382732
First received: June 24, 2011
Last updated: June 30, 2013
Last verified: June 2013

June 24, 2011
June 30, 2013
January 2012
December 2013   (final data collection date for primary outcome measure)
Need for additional uterotonics [ Time Frame: Six months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01382732 on ClinicalTrials.gov Archive Site
  • Development of oliguria [ Time Frame: six months ] [ Designated as safety issue: No ]
    Number of cases that develop oliguria (<30 mL/hr over a 2 hour period) after the administration of the drug.
  • Changes in hemodynamic status [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    Changes in Systolic pressure , dyastolic pressure, mean arterial pressure and heart rate one and two hours after the administration of the drug.
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Severe Preeclampsia
  • Postpartum Hemorrhage
  • 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
  • Experimental: 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

    Intervention: Drug: Carbetocin
  • Active Comparator: 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
    Intervention: Drug: Oxytocin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
636
January 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Twin pregnancy
  • Coagulation disorders
  • HELLP Syndrome
  • Eclampsia
Female
Not Provided
No
Panama
 
NCT01382732
MHST2011-06
No
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
Saint Thomas Hospital, Panama
Not Provided
Principal Investigator: Osvaldo A Reyes, MD Saint Thomas Hospital, Panama
Saint Thomas Hospital, Panama
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP