DRUG
Oxytocin
Oxytocin 10-5M will be added to 3 groups of myometrial strips for 2 hours to induce desensitization.
Status
Recruiting
Phase
Not applicable
Enrollment
40
Locations
1
Results
Not posted
Publications
0
Study summary
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.
Interventions
DRUG
Oxytocin 10-5M will be added to 3 groups of myometrial strips for 2 hours to induce desensitization.
DRUG
Increasing concentrations of carbetocin in a pattern of 1 log molar increase every 10 min, from 10-10 M to 10-5 M
DRUG
Calcium chloride in the following concentrations:1.25mM, 2.5mM and 5.0mM.
Timeline
First posted
Apr 16, 2025
Study start
Sep 15, 2025
Primary completion
Jun 2026
Study completion
Jun 2026
Results posted
Not reported
Registry updated
Sep 24, 2025
Outcomes
Motility index
Time frame · 4 hours
Motility index (MI) is a calculated outcome, based on the formula: frequency/(10 x amplitude). Frequency and amplitude are secondary outcome measures as described below. The analysis is undertaken by attaching myometrial strips between an isometric force transducer and the base of an organ bath chamber.
Amplitude of contraction
Time frame · 4 hours
The maximum extent of uterine muscle contraction, measured in grams (g). The analysis is undertaken by attaching myometrial strips between an isometric force transducer and the base of an organ bath chamber.
Frequency of contraction
Time frame · 4 hours
The number of contractions in uterine muscle (myometrium) over 10 minutes, spontaneously and in response to an agonist. The analysis is undertaken by attaching myometrial strips between an isometric force transducer and the base of an organ bath chamber.
Integrated area under response curve (AUC)
Time frame · 4 hours
Eligibility
Inclusion Criteria: * 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. Exclusion criteria: * patients requiring general anesthesia * more than 1 previous cesarean delivery * history of uterine atony * emergency cesarean section in labor * patients using medications that could affect myometrial contractility such as nifedipine, labetalol, or magnesium sulphate. * patients with any condition of predisposing to uterine atony and postpartum hemorrhage, such as abnormal placentation, multiple gestation, severe preeclampsia, macrosomia, polyhydroamnios, large uterine fibroids, chorioamnionitis, previous history of postpartum bleeding.
Study locations
Canada. Showing up to 24 locations stored in the fast local snapshot.
Mount Sinai Hospital
Toronto, Ontario, Canada
Publications
No PMID-linked publications were present in this registry snapshot.
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