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A Randomized Trial Comparing Oxytocin and Oxytocin + Ergometrine for Prevention of Postpartum Haemorrhage at Caesarean Section

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ClinicalTrials.gov Identifier: NCT02046499
Recruitment Status : Unknown
Verified January 2014 by Leon Snyman, University of Pretoria.
Recruitment status was:  Not yet recruiting
First Posted : January 27, 2014
Last Update Posted : January 27, 2014
Sponsor:
Information provided by (Responsible Party):
Leon Snyman, University of Pretoria

Brief Summary:
This is a randomized trial comparing oxytocin versus oxytocin + syntometrine in the prevention of post partum haemorrhage in patients undergoing caesarean section

Condition or disease Intervention/treatment Phase
Prevention of Post Partum Haemorrhage Drug: Oxytocin Drug: Oxytocin ergometrine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Trial Comparing Oxytocin and Oxytocin + Ergometrine for Prevention of Postpartum Haemorrhage at Caesarean Section
Study Start Date : January 2014
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Active Comparator: Oxytocin arm
Oxytocin alone administered which is current standard of care
Drug: Oxytocin
Oxytocin will be administered intravenously as per standard protocol

Experimental: Oxytocin + syntometrine
Oxytocin plus syntometrine administered
Drug: Oxytocin ergometrine
Oxytocin ergometrine will be administered intra-musculalry
Other Name: Syntometrine




Primary Outcome Measures :
  1. Blood loss [ Time Frame: 60 minutes ]
    Estimated blood loss at caesarean section


Secondary Outcome Measures :
  1. Side effects of oxytocin compared to oxytocin + ergometrine [ Time Frame: 24 hours ]
    Compare side effects experienced by women administered oxytocin compared to oxytocin plus ergometrine

  2. Need for additional uterotonics [ Time Frame: 60 minutes ]
    To determine the need for additional uterotonics to treat post partum haemorrhage

  3. Number of units blood transfused [ Time Frame: 24 hours ]
    Compare the number of units blood required for transfusion between the two arms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women delivering by caesarean section older than 18 years willing and able to give informed consent

Exclusion Criteria:

  • • Women not willing or women not able to provide consent

    • Women who have a classical caesarean section
    • Women younger than 18 years of age
    • Women with any of the following conditions will be excluded (ergometrine contra-indicated in patients with these conditions).
    • Pre- eclampsia
    • Eclampsia,
    • Uncontrolled hypertension (hypertension defined as systolic blood pressure more than 140 mm Hg and diastolic blood pressure more than 90 mm Hg)
    • Any cardiac lesion
    • Impaired liver function
    • Impaired kidney function
    • Hypersensitivity to any of the active ingredients of the preparations that will be used (Syntometrine® or Syntocinon®)
    • Occlusive vascular disease
    • Autoimmune vasculitis

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): NCT02046499


Contacts
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Contact: Leon C Snyman, MBChB, MMed +27834621818 leon.snyman@up.ac.za
Contact: Sandy Koen, MBChB +27767903940 sandy.koen@yahoo.com

Locations
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South Africa
Kalafong Academic Hospital Not yet recruiting
Pretoria, Gauteng, South Africa, 0001
Principal Investigator: Sandy Koen, MBChB         
Sponsors and Collaborators
University of Pretoria
Investigators
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Principal Investigator: Leon C Snyman, MbChB MMed Department Obstetrics & Gynaecology, University of Pretoria, South Africa

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Responsible Party: Leon Snyman, Principal Specialist, University of Pretoria
ClinicalTrials.gov Identifier: NCT02046499     History of Changes
Other Study ID Numbers: PPH Prevention Trial
First Posted: January 27, 2014    Key Record Dates
Last Update Posted: January 27, 2014
Last Verified: January 2014

Keywords provided by Leon Snyman, University of Pretoria:
Prevention, post partum haemorrhage

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