Effect of Extracellular Calcium on Carbetocin Mediated Contractility in Human Myometrium
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oxytocin, Carbetocin, Calcium.
- Who it may be relevant to
- Registry conditions: Postpartum Hemorrhage (Primary). Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Extracellular Calcium on Carbetocin Mediated Contractility in Human Myometrium: An Ex-Vivo Study
Overview
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
Oxytocin 10-5M will be added to 3 groups of myometrial strips for 2 hours to induce desensitization. - Drug Carbetocin
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
Calcium chloride in the following concentrations:1.25mM, 2.5mM and 5.0mM.
Primary outcome measures
- Motility index [Time frame: 4 hours]
Secondary outcome measures (3)
- Amplitude of contraction [Time frame: 4 hours]
- Frequency of contraction [Time frame: 4 hours]
- Integrated area under response curve (AUC) [Time frame: 4 hours]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Mount Sinai Hospital — Toronto
Identifiers
NCT: NCT06930391 · 25-01