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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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12 February 2013 |
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Main ID: |
ISRCTN98070045 |
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Date of registration:
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07/03/2012 |
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Primary sponsor: |
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Public title:
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A study on carbetocin (Pabal®) versus oxytocin (Syntocinon®)
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Scientific title:
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Study on the use of carbetocin (Pabal®) in comparison with oxytocin (Syntocinon®) for the prevention of postpartum haemorrhage (the need for additional uterotonic medication) after elective caesarean section |
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Date of first enrolment:
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Jul 1 2009 |
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Target sample size:
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1500 |
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Recruitment status: |
Completed/Not recruiting |
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URL:
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http://isrctn.org/ISRCTN98070045 |
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Study type:
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Observational |
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Study design:
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Open-label multi-centre observational study
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Hein
Bruinse |
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Address:
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University Medical Center Utrecht (WKZ)
Lundlaan 6
3584 EA
Utrecht
Netherlands |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Charts of women undergone elective CS under epidural and/or spinal anaesthesia and treated with carbetocin or oxytocin.
Exclusion criteria: Contraindications, warnings, precautions and interactions with other drugs mentioned in the summary of product characteristics of carbetocin and oxytocin.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Obstetrics / Caesarean section
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Intervention(s)
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After treatment on prescription with carbetocin or oxytocin, information will be gathered from the patient's chart. The follow-up time is 24 hours after medication administration.
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Primary Outcome(s)
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Need for additional uterotonic treatment during the first 24 hours after carbetocin or oxytocin administration.
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Secondary Outcome(s)
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1. Need for blood transfusion during the first 24 hours
2. Need for operative interventions other than the initial CS during the first 24 hours
3. Need for uterus massage during the first 24 hours
4. Change in haematocrit and haemoglobin post versus pre CS
5. Amount of intraoperative blood loss
6. Incidence of intraoperative blood loss > 500 ml
7. Incidence of intraoperative blood loss > 1000 ml
8. Position of fundus after wound closure (only in prospective part of the study)
9. Uterus tone after uterotonic treatment
10. Investigator?s subjective experience with oxytocin/carbetocin
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Source(s) of Monetary Support
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Ferring B.V. (Netherlands)
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