Mount Sinai Hospital
Toronto, Ontario, M5G1X5, Canada
NCT Number: NCT01869556
Patients having Cesarean section after they have been in labor for many hours bleed much more, in average twice as much, as compared with patients having an elective Cesarean section. The investigators believe a simple change in practice might contribute to reduce this bleeding. This study will involve the use of oxytocin (also known as syntocinon), ergonovine (also known as ergot) and carboprost (also known as hemabate). Oxytocin is routinely used to help contract the uterus and keep it contracted after the delivery of the baby and placenta, so as to reduce the amount of blood loss. Ergonovine is also given through the intravenous line, while carboprost is given as an injection in the muscle. Although they are not routinely given in every case, these are very frequently given as rescue medications to patients who fail to respond appropriately to oxytocin. This study is designed to determine if ergonovine or carboprost given in association with oxytocin, in a preventive way, after delivery of the baby and placenta, can reduce the amount of blood loss during Cesarean sections following a trial of labour.
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Notify Me14 year–55 year
Female
Interventional
Not applicable
Toronto, Ontario, M5G1X5, Canada
The objective of the investigators study is to compare the efficacy of intravenous ergonovine and intramuscular carboprost, when administered with oxytocin infusion, prophylactically to decrease blood loss at Cesarean section for labor arrest. Desensitization of the oxytocin receptors has been recently demonstrated in cultured human myometrial cells after continuous and prolonged exposure to oxytocin in-vitro. This could be also the reason for a greater risk of uterine atony and postpartum hemorrhage (PPH) seen in women requiring induction and augmentation of labor. Therefore, addition of a different uterotonic agent, involving a different mechanism of action, to oxytocin infusion is likely to be beneficial, especially in women undergoing CS following failure to progress in labor, who are at a greater risk for PPH.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oxytocin 5IU IV bolus, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours
Other names: syntocinon
Ergot 0.25mg IV
Other names: ergonovine maleate
Carboprost 0.25mg IM
Other names: Hemabate®
Time frame: 1 hour
Need for additional uterotonics intraoperatively if requested by the surgeon, YES or NO
Time frame: 10 min
Adequate/inadequate uterine tone at 3,5 & 10 min
Time frame: 24 hours
Any blood products administered
Time frame: 2 hours
In the OR, heart rate, blood pressure, and oxygen saturation will be measured and looked at for abnormalities
Time frame: 24 hours
The presence of nausea, vomiting,other dysrhythmias, chest pain, headache, bronchospasm and any others will be recorded.
Time frame: 48 hours
calculated blood loss = EBV (Pre-op Htc-Post-op Htc) EBV (estimated blood volume, mL)=patient's weight in kg x 85
Time frame: 24 hours
Need for additional uterotonics or interventions post-operatively up to 24 hours post-partum
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Other
Comparison of Intravenous Ergonovine With Intramuscular Carboprost, Both in Combination With Oxytocin Infusion, During Cesarean Section for Failure to Progress in Labor: A Double-blinded Placebo-controlled Randomized Controlled Trial
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