drugset / Trial / NCT06285409

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

NCT06285409

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-04-04
Primary completion
2026-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carbetocin Peptide 1e-05 unknown Other
Comparator Carbetocin Peptide 100 ug Other
Comparator Carboprost Unknown 1e-10 unknown
Comparator Carboprost Unknown 1e-05 unknown
Comparator Oxytocin Peptide 1e-10 unknown Other
Comparator Oxytocin Peptide 1e-05 unknown Other
Comparator ergometrine Unknown 1e-10 unknown
Comparator ergometrine Unknown 1e-05 unknown

Indications

No indication recorded.