Меню
Идёт набор NCT05177510

Mifepristone Outpatient Labour Induction

Фаза II С лечением Labor, Induced

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: Mifepristone, Placebo.
Кому может быть актуально
Состояния в реестре: Labor, Induced. Базовые параметры: от 18 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
Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

The number of women having an induction of labour is increasing and is currently used in 33% of pregnancies for a range of medical reasons. The majority of women are admitted to hospital to have their labour induced, using methods which are protracted and associated with a poor birth experience, making them both costly and unpopular. Further, current methods of outpatient induction are unsuitable, unsafe and/or have a poor acceptability. The COVID-19 pandemic has driven a reduction in the number of face-to-face interactions taking place across all areas of medicine. Proving the efficacy and safety of Mifepristone would significantly reduce pre-labour admission rates and hospital length of stay for pregnant women, who are at particularly higher risk of COVID-19, and reduce delivery costs.

Подробное описание

The study is a double blinded, two arms, multi-centre randomised controlled clinical trial to investigate the clinical effectiveness, safety and resource utilisation of intervention for the induction of labour in women admitted to the hospital. Subjects will be randomised 1:1 to one of the two arms to receive:

Arm 1: Mifepristone + standard of care Arm 2: Placebo + standard of care

The study treatment will commence from the administration of the Mifepristone or placebo. The participants will be assessed 2 days after treatment regimen will be completed as an in-patient.

Вмешательства

  • Препарат Mifepristone
    Progestin Antagonist
  • Препарат Placebo
    Placebo

Первичные конечные точки

  • Measure of women in labour or delivered within 2 days of intervention [Срок оценки: up to 2 days after administration of intervention]
Вторичные конечные точки (3)
  • Change in clinical outcomes [Срок оценки: up to 6 weeks after delivery]
  • Determine whether intervention reduces resource utilisation and patient experience [Срок оценки: after delivery and up to 6 weeks after delivery]
  • To assess the efficacy and safety of Mifepristone for the outpatient induction of labour [Срок оценки: up to 6 weeks after delivery]

Критерии участия

Критерии включения

  • Pregnant women between 36+5 and 41+5 weeks of gestation
  • Singleton pregnancy
  • Aged 18 years or older
  • Unfavourable cervix (Bishop Score less than or equal to 6)
  • The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements.

Критерии исключения

  • Breech presentation
  • Early labour
  • Contraindication to vaginal birth (placenta praevia, transverse lie, known or suspected cephalo-pelvic disproportion or other factor contraindicated to vaginal birth in the opinion of the investigator)
  • Fetal growth restriction with oligohydramnios and/or abnormal Dopplers
  • Presence of reduced fetal movements requiring urgent delivery, abnormal CTG or recent antepartum haemorrhage requiring immediate delivery
  • Medical conditions:

i. sexually transmitted infections (active infections only) ii. bleeding disorders, on anticoagulants, steroid or aspirin therapy iii. prior uterine operations (Caesarean Section or myomectomy)

  • Contra-indications to mifepristone including chronic adrenal, hepatic, renal failure
  • Hypersensitivity to mifepristone or to any excipients, or malnutrition
  • Severe asthma uncontrolled by therapy and inherited porphyria
  • Any investigational drug with an expected interaction with mifepristone which has been administered within 30 days prior to the trial drug administration.

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
Профилактика

Центры проведения

Великобритания · 1 центр
  • Chelsea and Westminster Hospital — London

Идентификаторы

NCT: NCT05177510 · CW003 · 2021-004860-93

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗