Carbetocin vs. Oxytocin for Prevention of Postpartum Bleeding in Patients With Severe Preeclampsia
NCT ID: NCT01382732
Last Updated: 2015-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
636 participants
INTERVENTIONAL
2012-01-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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
Carbetocin
Protocol A (carbetocin + placebo) Carbetocin: 100ug (1mL) + Ringer's Lactate 10mL directly into the vein in no less than two minutes.
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
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Severe pre-eclampsia
Exclusion Criteria
* Coagulation disorders
* HELLP Syndrome
* Eclampsia
FEMALE
No
Sponsors
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Saint Thomas Hospital, Panama
OTHER
Responsible Party
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Osvaldo A. Reyes T.
MD
Principal Investigators
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Osvaldo A Reyes, MD
Role: PRINCIPAL_INVESTIGATOR
Saint Thomas Hospital, Panama
Locations
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Saint Thomas H
Panama City, Provincia de Panamá, Panama
Countries
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Facility Contacts
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Other Identifiers
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MHST2011-06
Identifier Type: -
Identifier Source: org_study_id
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