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Идёт набор NCT05114096

Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)

Фаза IV С лечением Preterm Birth Premature Birth Complication of Prematurity Obstetric Labor, Premature

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: Celestone + placebo, Celestone + Celestone.
Кому может быть актуально
Состояния в реестре: Preterm Birth, Premature Birth, Complication of Prematurity, Obstetric Labor, Premature. Базовые параметры: 18 лет — 55 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Single Dose of Antenatal Corticosteroids (SNACS) Randomized Controlled Trial for Pregnancies at Risk of Preterm Delivery: To Keep Babies and Children Safe

Обзор

Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities in preterm infants, such as respiratory distress syndrome. The standard of care for pregnant people at risk of preterm birth includes 2 doses of Celestone (for a total of 24 mg in Canada, or 22.8 mg in Australia) to accelerate fetal lung maturity. The investigators plan to conduct a randomized controlled trial to determine whether half the usual dose (12 mg in Canada, or 11.4 mg in Australia) of Celestone is non-inferior to the standard double doses.

Подробное описание

Preterm infants are at risk of mortality and morbidity. Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities, such as respiratory distress syndrome.

The standard of care for pregnant people at risk of preterm birth includes 2 doses of Celestone to accelerate fetal lung maturity (total 24 mg in Canada, 22.8 mg in Australia). There are no published clinical trial data on the benefits or risks of a single dose of antenatal corticosteroid vs. standard double doses (Ninan et al JOGC 2020).

Pregnant people at 22 weeks and 0 days to \< 34 weeks and 6 days' gestation at risk of preterm birth with a singleton or twin gestation who have received the first dose of Celestone and consented to the trial will be randomized to receive approximately 24 hours later either an experimental placebo injection (of normal saline) or the standard double dose of Celestone to determine whether the intervention is non-inferior for the primary outcome of a composite of perinatal mortality or substantial morbidity.

Please note: Based on Health Canada's' guidance the study phase is 'Other: Off-Label use'. However, on the clincaltrial.gov record, 'Phase 4' is selected as this is the most relevant phase and there is no option to select 'Other'.

Please note: McMaster University, Canada is the Canadian Regulatory Sponsor and Overall Sponsor, and the University of Adelaide Australia is the Australian Sponsor.

Вмешательства

  • Препарат Celestone + placebo
    After the first intramuscular injection of Celestone, participants randomized to the "Placebo Comparator" group will receive 1 intramuscular injection of placebo.
  • Препарат Celestone + Celestone
    After the first intramuscular injection of Celestone, participants randomized to the "Active Comparator" group will receive 1 intramuscular injection of Celestone.

Первичные конечные точки

  • Perinatal Mortality or Substantial Neonatal Morbidity [Срок оценки: approximately 1 month]
Вторичные конечные точки (1)
  • Death or neurosensory/developmental impairment at 24 months [Срок оценки: approximately 24 months]

Критерии участия

Критерии включения

  • Pregnant people, aged 18 to 55 years old, at risk of preterm birth with a singleton or twins between 22 weeks and 0 days and <34 weeks and 6 days gestation who have received only a single dose of Celestone within 24 hours
  • Capable of giving informed, written consent.

Критерии исключения

  • Contraindication to corticosteroids
  • Systemic corticosteroids for medical conditions during the pregnancy (e.g. lupus, severe asthma, Covid, etc).
  • Previous participation in this trial (in a previous pregnancy)
  • Known severe/life-threatening fetal or pregnant patient condition (e.g. fetal congenital/chromosomal abnormality)
  • Demise of one or more fetuses after 14 weeks and 0 days

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Другое

Центры проведения

Канада · 25 центров
  • University of Calgary, Cumming School of Medicine — Calgary
  • Alberta Health Services; University of Alberta — Edmonton
  • Royal Columbian Hospital — New Westminster
  • Fraser Health, University of British Columbia; Jim Pattison Outpatient Care and Surgery Ce — Surrey
  • University of British Columbia; BC Women's Hospital — Vancouver
  • Victoria General Hospital — Victoria
  • University of Manitoba, Health Sciences Centre — Winnipeg
  • University of Manitoba; St. Boniface General Hospital — Winnipeg
  • … и ещё 17 центров

Публикации

  • Ninan K, Morfaw F, Murphy KE, Beyene J, McDonald SD. Neonatal and Maternal Outcomes of Lower Versus Standard Doses of Antenatal Corticosteroids for Women at Risk of Preterm Delivery: A Systematic Review of Randomized Controlled Trials. J Obstet Gynaecol Can. 2021 Jan;43(1):74-81. doi: 10.1016/j.jogc.2020.02.127. Epub 2020 Mar 26. PMID 32660867

Идентификаторы

NCT: NCT05114096 · 3764

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗