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Trial record 14 of 618 for:    Hemorrhage AND postpartum

Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section

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ClinicalTrials.gov Identifier: NCT02044549
Recruitment Status : Completed
First Posted : January 24, 2014
Last Update Posted : January 24, 2014
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, Cairo University

Brief Summary:
to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of Postpartum hemorrhage after cesarean section

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Blood Loss Drug: carbetocin Drug: Syntometrine Phase 4

Detailed Description:

A double blind randomized study conducted on 450 pregnant subjected randomly either to single 100 μg IV dose of carbetocin (150 women) or combination of 5 IU oxytocin and 0.2 mg ergometrine (300 women) after fetal extraction and before placental removal.

Prevention of postpartum haemorrhage (PPH) after cesarean section (CS) had been evaluated by measurement of drop of Hemoglobin and hematocrit, incidence of PPH and number of subjects needed additional oxytocic


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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section
Study Start Date : June 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: carbetocin
single 100 μg IV dose of carbetocin (150 women) after fetal extraction and before placental removal.
Drug: carbetocin
Oxycontin analogue
Other Name: Pabal

Active Comparator: Syntometrine
Intravenous combination of 5 IU oxytocin and 0.2 mg ergometrine (300 women) after fetal extraction and before placental removal.
Drug: Syntometrine
Uterotonins
Other Name: Oxytocin methergine combination




Primary Outcome Measures :
  1. prevention of post partum hemorrhage after CS [ Time Frame: 24 hours ]
    Number of participants experienced postpartum hemorrhage


Secondary Outcome Measures :
  1. side effects of drugs used [ Time Frame: 24 hours ]
    Number of subjects experienced Hemodynamic changes (blood pressure , pulse and respiratory rate ) , GIT side effects as nausea , vomiting and metallic taste, Vasomotor effects as flushing, headache , itching



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All participants are at 37 - 40 weeks of gestational age
  • Noncomplicated pregnancy.

Exclusion Criteria:

  • Participants with placenta previa
  • Patients with coagulopathy
  • preeclamptic women
  • known sensitivity to oxytocin or methergine were excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044549


Locations
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Egypt
Ahmed Maged
Cairo, Egypt, 12151
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Maged, MD Ass prof kasr aini medical school

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Responsible Party: Ahmed Maged, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT02044549     History of Changes
Other Study ID Numbers: Carbitocin
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: January 24, 2014
Last Verified: January 2014

Keywords provided by Ahmed Maged, Cairo University:
Carbetocin
syntometrine
postpartum hemorrhage
cesarean section

Additional relevant MeSH terms:
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Hemorrhage
Postpartum Hemorrhage
Puerperal Disorders
Uterine Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Oxytocin
Carbetocin
Syntometrine
Ergonovine
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs