Clinical Trial: Comparison of IV Ergonovine With IM Carboprost, With Oxytocin IV, During Cesarean Section for Failure to Progress

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Comparison of Intravenous Ergonovine With Intramuscular Carboprost, Both in Combination With Oxytocin Infusion, During Cesarean Section for Failure to Progress in Labor: A

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Current Primary Outcome: Estimated blood loss [ Time Frame: 72 hours ]

calculated blood loss = EBV (Pre-op Htc-Post-op Htc) EBV (estimated blood volume, mL)=patient's weight in kg x 85


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Effectiveness of uterine contraction [ Time Frame: 24 hours ]
    • Adequate/inadequate uterine tone at 5 min
    • Need for additional uterotonics intraoperatively as requested by the obstetrician
    • Need for additional uterotonics or interventions in the first 24 hours post-partum
  • Need for blood transfusion [ Time Frame: 24 hours ]
  • Vital signs [ Time Frame: 2 hours ]
    In the OR, heart rate, blood pressure, and oxygen saturation will be measured and looked at for abnormalities
  • Side effects [ Time Frame: 24 hours ]
    The presence of nausea, vomiting,other dysrhythmias, chest pain, headache, bronchospasm and any others will be recorded.


Original Secondary Outcome: Same as current

Information By: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Dates:
Date Received: May 31, 2013
Date Started: May 2013
Date Completion: April 2017
Last Updated: April 29, 2016
Last Verified: April 2016