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

Официальное название

Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery: a Double-blind Randomized Control Trial

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Uterine Tone 10 minutes [Срок оценки: 10 minutes]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Mount Sinai Hospital — Toronto

Идентификаторы

NCT: NCT07187544 · 25-02 · 300140

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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