Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital

About this trial

This study will investigate the effects of drugs called "uterotonics" that help with the contraction of the uterus after a baby is born. This uterine contraction is very important to stop the bleeding after delivery. An uncontracted uterine state is called "uterine atony", which can lead to an excessive amount of post-delivery bleeding. Carbetocin is an uterotonic drug that works well to prevent post-delivery bleeding. In some cases, carbetocin is not enough to contract the uterus, and ongoing bleeding continues. When that happens, there are other uterotonic medications that can be used. In this study, we aim to find which uterotonic drug, amongst those available (oxytocin, carbetocin, ergometrine or carboprost), is more effective to lower the risk of post-delivery bleeding once carbetocin has already been administered.

This study will be done by using a very small sample of uterine tissue, taken from the incision site, following delivery by cesarean section. The sample is taken to the laboratory and will be exposed to carbetocin followed by other uterotonic drugs. The information obtained from this study will help modify the treatment for uterine atony and post-delivery bleeding to lower the risk further.

Eligibility criteria

Qualifiers

Patients who give written consent to participate in this study

Patients with gestational age 37-41 weeks

Non-laboring patients, not exposed to exogenous oxytocin

Patients requiring elective primary or first repeat CD

Disqualifiers

Patient refusal

Patients who require general anesthesia

Patients in labour and those receiving oxytocin for induction of labour

Emergency CD

Trial design

Treatments tested in this trial

  • Carbetocin
  • Oxytocin
  • Carbetocin
  • Oxytocin
  • Ergonovine
  • Carboprost

Treatment groups

32 Participants
are divided into 5 treatment groups