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
  Purpose

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.


Condition Intervention Phase
Severe Preeclampsia
Postpartum Hemorrhage
Drug: Carbetocin
Drug: Oxytocin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Carbetocin Versus Oxytocin for Prevention of Postpartum Hemorrhage in Patients With Severe Preeclampsia: a Double Blind Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Saint Thomas Hospital, Panama:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 636
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Twin pregnancy
  • Coagulation disorders
  • HELLP Syndrome
  • Eclampsia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01382732

Locations
Panama
Saint Thomas H Recruiting
Panama, Panama
Contact: Osvaldo A Reyes, MD    o11(507)65655041    oreyespanama@yahoo.es   
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Investigators
Principal Investigator: Osvaldo A Reyes, MD Saint Thomas Hospital, Panama
  More Information

No publications provided

Responsible Party: Osvaldo A. Reyes T., MD, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT01382732     History of Changes
Other Study ID Numbers: MHST2011-06
Study First Received: June 24, 2011
Last Updated: June 30, 2013
Health Authority: Panama: Ministry of Health

Keywords provided by Saint Thomas Hospital, Panama:
Pre-eclampsia
Postpartum hemorrhage
Carbetocin
Oxytocin

Additional relevant MeSH terms:
Hemorrhage
Pre-Eclampsia
Postpartum Hemorrhage
Pathologic Processes
Hypertension, Pregnancy-Induced
Pregnancy Complications
Obstetric Labor Complications
Puerperal Disorders
Uterine Hemorrhage
Oxytocin
Carbetocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014