Not Yet RecruitingPhase 2ACTRN12612000466842

Carbetocin vs Oxytocin at Emergency Caesarean Section

Carbetocin vs Oxytocin (Syntocinon) to Improve Uterine Tone at Emergency Caesarean Section


Sponsor

Carole-anne Whigham

Enrollment

130 participants

Start Date

Aug 1, 2012

Study Type

Interventional

Conditions

Summary

Reducing maternal mortality rates has been a worldwide goal for many years. Post partum haemorrhage is the main cause of obstetric haemorrhage accounting for 14 million cases worldwide. It is the leading cause of maternal death throughout the world. In Victoria, Australia, in 2002 the post partum haemorrhage rate was 9.2%. Post partum haemorrhage is associated with ICU admission, the need for blood transfusion and a longer hospital stay, which is at considerable cost. The majority of post partum haemorrhage is caused by uterine atony, so finding an effective agent to prevent uterine atony is paramount in reducing maternal morbidity and mortality. Operative delivery is a known risk factor for PPH therefore improving uterine tone at caesarean section is an important parameter if rates are to be reduced. Carbetocin is a synthetic long-acting analogue of oxytocin used to improve uterine tone. Studies have shown that a single intra-muscular injection of carbetocin is more effective than syntocinon infusion for preventing uterine atony at elective caesarean section, and this is the current practice at Frankston Hospital. Carbetocin is currently licensed in Australia to reduce uterine atony at elective caesarean section, however the efficacy at emergency caesarean section is unclear. In this prospective randomised trial we aim to discover if carbetocin 100 micrograms iv or Syntocinon 5 unit iv bolus, is more effective at improving post partum haemorrhage rates in emergency caesarean sections, by measures of need for further uterotonics, need for >5 minutes uterine massage and haemoglobin drop.


Eligibility

Sex: FemalesMin Age: 17 YearssMax Age: 50 Yearss

Inclusion Criteria1

  • anyone having an emergency caesarean section at Frankston Hospital who have given consent to be part of the trial. Age>16. >37 weeks gestation. <3 previous caesarean sections. epidural or spinal anaesthesia

Exclusion Criteria1

  • previous adverse reaction to carbetocin/syntocinon. History of vascular, hepatic or renal problems. Lack of consent. <37 weeks gestation. Placenta praevia. Placental abruption. >2 caesarean sections. Patients having an elective caesarean section. general anaesthetic

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Interventions

100 microgram intravenous(IV) injection of carbetocin will be given immediately after delivery of the baby at emergency caesarean section.

100 microgram intravenous(IV) injection of carbetocin will be given immediately after delivery of the baby at emergency caesarean section.


Locations(1)

Australia

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ACTRN12612000466842