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

Primary Purpose

Severe Preeclampsia, Postpartum Hemorrhage

Status
Unknown status
Phase
Phase 3
Locations
Panama
Study Type
Interventional
Intervention
Carbetocin
Oxytocin
Sponsored by
Saint Thomas Hospital, Panama
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Severe Preeclampsia focused on measuring Pre-eclampsia, Postpartum hemorrhage, Carbetocin, Oxytocin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Twin pregnancy
  • Coagulation disorders
  • HELLP Syndrome
  • Eclampsia

Sites / Locations

  • Saint Thomas HRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Carbetocin

Oxytocin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Development of oliguria
Number of cases that develop oliguria (<30 mL/hr over a 2 hour period) after the administration of the drug.
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.

Full Information

First Posted
June 24, 2011
Last Updated
January 1, 2015
Sponsor
Saint Thomas Hospital, Panama
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1. Study Identification

Unique Protocol Identification Number
NCT01382732
Brief Title
Carbetocin vs. Oxytocin for Prevention of Postpartum Bleeding in Patients With Severe Preeclampsia
Official Title
Carbetocin Versus Oxytocin for Prevention of Postpartum Hemorrhage in Patients With Severe Preeclampsia: a Double Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Thomas Hospital, Panama

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Preeclampsia, Postpartum Hemorrhage
Keywords
Pre-eclampsia, Postpartum hemorrhage, Carbetocin, Oxytocin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
636 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carbetocin
Arm Type
Experimental
Arm Description
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
Arm Title
Oxytocin
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Carbetocin
Other Intervention Name(s)
Lonactene
Intervention Description
Protocol A (carbetocin + placebo) Carbetocin: 100ug (1mL) + Ringer's Lactate 10mL directly into the vein in no less than two minutes.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Pitocin
Intervention Description
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 Measure Information:
Title
Need for additional uterotonics
Description
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.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Development of oliguria
Description
Number of cases that develop oliguria (<30 mL/hr over a 2 hour period) after the administration of the drug.
Time Frame
six months
Title
Changes in hemodynamic status
Description
Changes in Systolic pressure , dyastolic pressure, mean arterial pressure and heart rate one and two hours after the administration of the drug.
Time Frame
six months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant women between 28 weeks and term Severe pre-eclampsia Exclusion Criteria: Twin pregnancy Coagulation disorders HELLP Syndrome Eclampsia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osvaldo A Reyes, MD
Organizational Affiliation
Saint Thomas Hospital, Panama
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Thomas H
City
Panama
Country
Panama
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osvaldo A Reyes, MD
Phone
o11(507)65655041
Email
oreyespanama@yahoo.es

12. IPD Sharing Statement

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

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