Current partner codePEPTIDESDE
NCT06930391·Not applicable·INTERVENTIONAL

Effect of Extracellular Calcium on Carbetocin Mediated Contractility in Human Myometrium

Status

Recruiting

Phase

Not applicable

Enrollment

40

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Apr 16, 2025

  2. Study start

    Sep 15, 2025

  3. Primary completion

    Jun 2026

  4. Study completion

    Jun 2026

  5. Results posted

    Not reported

  6. Registry updated

    Sep 24, 2025

Outcomes

What the study measures.

Primary 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.

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
40 Years
Sex
FEMALE
Healthy volunteers
Yes

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

1 registered sites.

Canada. Showing up to 24 locations stored in the fast local snapshot.

Mount Sinai Hospital

Toronto, Ontario, Canada

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Carbetocin.

Related PeptideStat pages

Put the record in context.

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