Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00499005
Status:
COMPLETED
Last Update Posted:
2009-09-21
First Post:
2007-07-09
Brief Title:
Carbetocin Versus Syntometrine for the Third Stage of Labour
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
Carbetocin Versus Syntometrine for the Third Stage of Labour Following Vaginal Delivery - A Double-blind Randomised Trial
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Intramuscular carbetocin is as effective as intramuscular syntometrine for the prevention of postpartum haemorrhage
Detailed Description:
Postpartum haemorrhagePPHor 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 2001Among the various agents that have been studied in addition to the routine oxytocin and syntometrine which has adverse effectsoxytocin agonist carbetocin appears to be the most promising for this indicationChong 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 propertiesThe 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 hourIntramuscular 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 significantHunter 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
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 propertiesThe 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 hourIntramuscular 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 significantHunter 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NHG-SIG07059 | None | None | None |