Effect of Extracellular Calcium on Carbetocin Mediated Contractility in Human Myometrium

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

patients requiring general anesthesia

more than 1 previous cesarean delivery

history of uterine atony

emergency cesarean section in labor

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oxytocin

    Drug

    Oxytocin 10-5M will be added to 3 groups of myometrial strips for 2 hours to induce desensitization.

  • Carbetocin

    Drug

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

  • Calcium

    Drug

    Calcium chloride in the following concentrations:1.25mM, 2.5mM and 5.0mM.

Treatment groups

40 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Calcium 1.25nM with NO oxytocin pre-exposureActive comparator 2 interventions
Group B: Calcium 2.5nM with NO oxytocin pre-exposureActive comparator 2 interventions
Group C: Calcium 5.0nM with NO oxytocin pre-exposureActive comparator 2 interventions
Group D: Calcium 1.25nM with oxytocin pre-exposureActive comparator 3 interventions
Group E: Calcium 2.5nM with oxytocin pre-exposureActive comparator 3 interventions
Group F: Calcium 5.0nM with oxytocin pre-exposureActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Motility index

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.

Time frame
4 hours

Secondary outcomes

1

Amplitude of contraction

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.

Time frame
4 hours
2

Frequency of contraction

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.

Time frame
4 hours
3

Integrated area under response curve (AUC)

Time frame
4 hours

Other outcomes

Sponsors and contacts

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