Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
32 participants
Apr 4, 2024
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria5
- 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
- Patients undergoing CD under spinal anesthesia
Exclusion Criteria8
- Patient refusal
- Patients who require general anesthesia
- Patients in labour and those receiving oxytocin for induction of labour
- Emergency CD
- placenta accreta spectrum disorder
- Patients who have had previous uterine surgery or >1 previous CD
- Patients with any condition predisposing to uterine atony and PPH (BMI > 40 kg/m2,
- Patients on medications that could affect myometrial contractility, such as insulin, nifedipine, labetalol or magnesium sulphate.
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Interventions
Carbetocin first bolus 10-8 M (equivalent to 100 mcg) will be added to the muscle bath to create ex-vivo environment similar to Cesarean delivery, and after 20 minutes the baths will be washed three time with physiological salt solution (PSS).
Oxytocin 10-5M will be added to all strips for 2 hours to induce desensitization.
Increasing concentrations of carbetocin in a pattern of 1 log molar increase every 10 min, from 10-5 M to 10-5 M
Increasing concentrations of oxytocin from 10-10 M to 10-5 M
Increasing concentrations of ergometrine from 10-10 M to 10-5 M
Increasing concentrations of carboprost from 10-10 M to 10-5 M
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06285409