Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
FEMALE
Healthy Volunteers
NCT06930391

Effect of Extracellular Calcium on Carbetocin Mediated Contractility in Human Myometrium

Led by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Updated on 2025-09-24

40

Participants Needed

1

Research Sites

37 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Postpartum hemorrhage (PPH) continues to be an increasing problem globally. Uterotonics play an essential role in the pharmacological management of uterine atony. Carbetocin, a long acting analog of oxytocin has been recommended as a first line uterotonic for PPH prophylaxis at cesarean delivery. Considering many woman have associated comorbidities and are at high risk of PPH, finding alternative pharmacological agents is essential. Calcium is a key factor for myometrial contractions and calcium blood levels can be low at the end of pregnancy. Both hypocalcemia and hypercalcemia could lead to a decrease in myometrial contractions. It is already been demonstrated that in both desensitized and naïve myometrium, normocalcemia provides a better uterine tone compared to hypo and hypercalcemia when oxytocin is given as the first uterotonic drug. Currently, the role of extracelullar calcium in carbetocin- induced contractility is unknown. This will be the first ex vivo study to test the effects of extracellular calcium on oxytocin pretreated and naive myometrium. The results of this study will provide evidence on the use of this safe drug in clinical practice, particularly in women with labour arrest, and provide alternative pharmacological strategies to both prevention and treatment of PPH, thus improving our clinical practice. The investigators hypothesize that extracellular normocalcemia would provide superior carbetocin-mediated contractility in both naive and oxytocin-pretreated myometrium compared with hypercalcemia and hypocalcemia.

CONDITIONS

Official Title

Effect of Extracellular Calcium on Carbetocin Mediated Contractility in Human Myometrium

Who Can Participate

Age: 18Years - 40Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Non-laboring women with gestational age between 37 to 41 weeks
  • Not exposed to exogenous oxytocin
  • Scheduled for a primary or first repeat cesarean delivery under neuraxial anesthesia
Not Eligible

You will not qualify if you...

  • Patients requiring general anesthesia
  • More than 1 previous cesarean delivery
  • History of uterine atony
  • Emergency cesarean section in labor
  • Use of medications affecting myometrial contractility such as nifedipine, labetalol, or magnesium sulphate
  • Conditions predisposing to uterine atony and postpartum hemorrhage including abnormal placentation, multiple gestation, severe preeclampsia, macrosomia, polyhydramnios, large uterine fibroids, chorioamnionitis, or previous postpartum bleeding

AI-Screening

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Trial Site Locations

Total: 1 location

1

Mount Sinai Hospital

Toronto, Ontario, Canada, M5G1X5

Actively Recruiting

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Research Team

M

Mrinalini Balki, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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