Carbetocin Versus Syntometrine for the Third Stage of Labour
| Tracking Information | |||||
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| First Received Date ICMJE | July 9, 2007 | ||||
| Last Updated Date | September 18, 2009 | ||||
| Start Date ICMJE | November 2006 | ||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
1. Postpartum haemorrhage (less than or equal to 500 ml) 2. Postpartum haemorrhage (less than or equal to 1000ml) 3. Use of additional uterotonic therapy [ Time Frame: Within 2 hours after delivery ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
1. Postpartum haemorrhage (less than or equal to 500 ml) 2. Postpartum haemorrhage (less than or equal to 1000ml) 3. Use of additional uterotonic therapy [ Time Frame: Within 2 hours after delivery ] | ||||
| Change History | Complete list of historical versions of study NCT00499005 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
1. Adverse effects with the intervention which include headache, nausea, vomiting, elevation of blood pressure and retained placenta 2. Cost effectiveness analysis of the intervention [ Time Frame: Within 2 hours after delivery ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE |
1. Adverse effects with the intervention which include headache, nausea, vomiting, elevation of blood pressure and retained placenta 2. Cost effectiveness analysis of the intervention [ Time Frame: Within 2 hours after delivery ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Carbetocin Versus Syntometrine for the Third Stage of Labour | ||||
| Official Title ICMJE | Carbetocin Versus Syntometrine for the Third Stage of Labour Following Vaginal Delivery - A Double-blind Randomised Trial | ||||
| Brief Summary | Intramuscular carbetocin is as effective as intramuscular syntometrine for the prevention of postpartum haemorrhage |
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| Detailed Description | Postpartum haemorrhage(PPH)or excessive bleeding at or after childbirth is a potentially life threatening complication and is one of the major contributors to maternal mortality and morbidity worldwide (Lewis 2001).Among the various agents that have been studied in addition to the routine oxytocin and syntometrine (which has adverse effects),oxytocin agonist (carbetocin) appears to be the most promising for this indication(Chong 2004). Carbetocin is a licensed medication for the use of prevention of postpartum haemorrhage in Singapore and many other countries. It is a long-acting synthetic octapeptide analogue of oxytocin with agonist properties.The clinical and pharmacological properties of carbetocin are similar to those of naturally occurring oxytocin. Like oxytocin, carbetocin binds to oxytocin receptors present on the smooth musculature of the uterus, resulting in rhythmic contractions of the uterus, increased frequency of existing contractions, and increased uterine tone. In pharmacokinetic studies, intravenous injections of carbetocin produced tetanic uterine contractions within two minutes, lasting six minutes, followed by rhythmic contractions for a further hour.Intramuscular injection produced tetanic contractions in less than two minutes, lasting about 11 minutes, and followed by rhythmic contractions for an additional two hours. The prolonged duration of activity after intramuscular compared with the intravenous carbetocin was significant(Hunter 1992). In comparison to oxytocin, carbetocin induces a prolonged uterine response when administered postpartum, in terms of both amplitude and frequency of contractions. The potential advantage of intramuscular carbetocin over intramuscular oxytocin is its longer duration of action. Its relative lack of gastrointestinal and cardiovascular side-effects should also prove advantageous compared to syntometrine and other ergot alkaloids. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) |
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| Condition ICMJE | Postpartum Haemorrhage | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 720 | ||||
| Completion Date | July 2009 | ||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Singapore | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00499005 | ||||
| Other Study ID Numbers ICMJE | DSRB Ref: D/04/209, NHG-SIG/07059 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Chong Yap Seng, MBBS, National HealthCare Group, Singapore | ||||
| Study Sponsor ICMJE | National University Hospital, Singapore | ||||
| Collaborators ICMJE | National Healthcare Group, Singapore | ||||
| Investigators ICMJE |
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| Information Provided By | National University Hospital, Singapore | ||||
| Verification Date | September 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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