Recruiting

Uterotonics

Sponsor:

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Code:

NCT06285409

Conditions

Postpartum Hemorrhage

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Carbetocin

Oxytocin

Carbetocin

Oxytocin

Ergonovine

Study Details

Brief 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.

Conditions

Postpartum Hemorrhage

Study ID

NCT06285409

Start date

Apr 4, 2024

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion criteria

  • 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 criteria

  • 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.

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Carbetocin

Dose-response testing with increasing concentrations of carbetocin in a pattern of 1 log molar increase every 10 min, from 10-5 M to 10-5 M

active comparator: Oxytocin

Dose-response testing with increasing concentrations of oxytocin from 10-10 M to 10-5 M.

active comparator: Ergometrine

Dose-response testing with increasing concentrations of ergometrine from 10-10 M to 10-5 M

active comparator: Carboprost

Dose-response testing with increasing concentrations of carboprost from 10-10 M to 10-5 M

placebo comparator: Control

No drug added to physiological salt solution (PSS).

Interventions

Carbetocin

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

Oxytocin 10-5M will be added to all strips for 2 hours to induce desensitization.

Carbetocin

Increasing concentrations of carbetocin in a pattern of 1 log molar increase every 10 min, from 10-5 M to 10-5 M

Oxytocin

Increasing concentrations of oxytocin from 10-10 M to 10-5 M

Ergonovine

Increasing concentrations of ergometrine from 10-10 M to 10-5 M

Carboprost

Increasing concentrations of carboprost from 10-10 M to 10-5 M

Primary outcome measure

  • Motility index [ Time Frame: 4 hours ]

Central Contacts and Locations

Central contacts

Mrinalini Balki, MD

416-586-4800mrinalini.balki@uhn.ca

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G1X5

Contacts

Mrinalini Balki, MD

416-586-4800mrinalini.balki@uhn.ca

More Information

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Last update posted

Apr 6, 2026

Last verified

Mar, 2026

Keywords

  • carbetocin
  • duratocin
  • oxytocin
  • uterine contraction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Samuel Lunenfeld Research Institute, Mount Sinai Hospital on 2026-04-06.