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Идёт набор NCT07187544

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

Без фазы С лечением Postpartum Hemorrhage (Primary)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Calcium Chloride, Placebo, Carbetocin.
Кому может быть актуально
Состояния в реестре: Postpartum Hemorrhage (Primary). Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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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)

Открыть это исследование на ClinicalTrials.gov ↗