Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital

About this trial

Postpartum hemorrhage (PPH) is a leading cause of maternal mortality, and its severity has been increasing globally, including in high-income countries. The most common cause of PPH is uterine atony occurring in about 70% of cases. Uterotonic agents, like oxytocin, are key in managing the third stage of labour to prevent PPH. Oxytocin is a short-acting medication and requires frequent dosing, however, carbetocin, a longer-acting analogue that can be administered as a single dose, provides sustained uterotonic activity. Calcium chloride is a readily available, inexpensive medication that has been studied as an adjunct to primary uterotonics due to its role in uterine contractility. A randomized trial found no overall reduction in blood loss with calcium chloride and oxytocin, but a subgroup analysis suggested it may reduce bleeding in cases of uterine atony. This study was conducted in the US where carbetocin is not readily available. The investigators propose a double-blind randomized trial investigating if co-administering calcium chloride with carbetocin during scheduled cesarean deliveries reduces PPH secondary to uterine atony.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Scheduled CD for patients ≥ 37 weeks excluding high risk factors for uterine atony

Neuraxial anesthesia as the primary anesthetic where intrathecal medications are the primary anesthetic

Disqualifiers

Overdistended uterus due to fetal macrosomia reported on prenatal ultrasound >90th centile or > 4000 gm, multiple gestation, grand multiparity (≥5 births at ≥ 20 weeks gestation), polyhydramnios

History of uterine atony/PPH (documented with blood loss > 2000 ml, blood transfusion, use of surgical methods such as Bakri balloon, B-Lynch sutures, uterine artery ligation or embolization)

Obesity with body mass index (BMI) > 40 kg/m2

Placenta previa and/or placenta accreta

Trial design

Design model

Parallel

Treatments tested in this trial

  • Calcium Chloride

    Drug

    Intravenous calcium chloride 10% (1g) will be administered in 100ml normal saline, over 10 minutes.

  • Placebo

    Other intervention

    Intravenous administration of 100ml normal saline, over 10 minutes.

  • Carbetocin

    Drug

    50 mcg intravenous carbetocin.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: CalciumActive comparator 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Uterine Tone 10 minutes

The intensity of uterine tone as evaluated by palpation of the uterus by the obstetrician at 10 minutes post-fetal delivery, utilizing a verbal numeric rating scale of 0-10.

Time frame
10 minutes

Secondary outcomes

1

Uterine Tone baseline

The intensity of uterine tone as evaluated by palpation of the uterus by the obstetrician after delivery of the placenta, utilizing a verbal numeric rating scale of 0-10.

Time frame
1 minute
2

Uterine Tone 5 minutes

The intensity of uterine tone as evaluated by palpation of the uterus by the obstetrician at 10 minutes post-fetal delivery, utilizing a verbal numeric rating scale of 0-10.

Time frame
5 minutes
3

Uterine Tone 15 minutes

The intensity of uterine tone as evaluated by palpation of the uterus by the obstetrician at 15 minutes post-fetal delivery, utilizing a verbal numeric rating scale of 0-10.

Time frame
15 minutes
4

Uterine Tone 20 minutes

The intensity of uterine tone as evaluated by palpation of the uterus by the obstetrician at 20 minutes post-fetal delivery, utilizing a verbal numeric rating scale of 0-10.

Time frame
20 minutes

Other outcomes

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