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Recruiting NCT07187544

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

No phase Interventional Postpartum Hemorrhage (Primary)

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: Calcium Chloride, Placebo, Carbetocin.
Who it may be relevant to
Registry conditions: Postpartum Hemorrhage (Primary). Basic parameters: 18 years — 45 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 Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery: a Double-blind Randomized Control Trial

Overview

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.

Interventions

  • Drug Calcium Chloride
    Intravenous calcium chloride 10% (1g) will be administered in 100ml normal saline, over 10 minutes.
  • Other Placebo
    Intravenous administration of 100ml normal saline, over 10 minutes.
  • Drug Carbetocin
    50 mcg intravenous carbetocin.

Primary outcome measures

  • Uterine Tone 10 minutes [Time frame: 10 minutes]
Secondary outcome measures (12)
  • Uterine Tone baseline [Time frame: 1 minute]
  • Uterine Tone 5 minutes [Time frame: 5 minutes]
  • Uterine Tone 15 minutes [Time frame: 15 minutes]
  • Uterine Tone 20 minutes [Time frame: 20 minutes]
  • Additional uterotonic agents required intraoperatively [Time frame: 90 minutes]
  • Additional uterotonic agents required post-operatively [Time frame: 24 hours]
  • Semi-quantitative blood loss (SQBL) [Time frame: 90 minutes]
  • Incidence of postpartum hemorrhage [Time frame: 24 hours]
  • Presence of blood transfusion [Time frame: 24 hours]
  • Number of patients with conservative surgical methods to manage post partum hemorrhage [Time frame: 2 hours]
  • Number of patients with radiological methods used to manage post partum hemorrhage [Time frame: 2 hours]
  • Obstetric Quality of Recovery-10 (ObsQoR-10) score 24 hours [Time frame: 24 hours]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Risk factors for uterine atony including:
  • 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
  • Digoxin therapy within 14 days (hypercalcemia can exacerbate digoxin toxicity)
  • Patients needing intraoperative IV ceftriaxone or tetracycline.
  • Kidney disease including Stage 3 chronic kidney disease, serum creatinine above 120 mmol/L or GFR <60 ml/min (to prevent hypercalcemia due to reduced creatinine clearance in those with impaired kidney function as calcium is renally excreted)
  • Calcium channel blockade within 24 hours (opposing effect)
  • Known history of cardiac disease including arrhythmias, ischemia, and congenital heart disease (to avoid attributing cardiac symptoms to study drugs)
  • Preexisting hypertension, preeclampsia or persistent elevated blood pressure above 160/100 mmHg requiring treatment
  • Emergency cesarean deliveries or women in labor
  • Planned general anesthetic for patients where neuraxial is contraindicated.

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
Quadruple blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Mount Sinai Hospital — Toronto

Identifiers

NCT: NCT07187544 · 25-02 · 300140

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗