Postpartum Haemorrhage Clinical Trial
Official title:
Carbetocin Versus Syntometrine for the Third Stage of Labour Following Vaginal Delivery - A Double-blind Randomised Trial
Intramuscular carbetocin is as effective as intramuscular syntometrine for the prevention of postpartum haemorrhage
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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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
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