Mifepristone Outpatient Labour Induction
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Measure of women in labour or delivered within 2 days of intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a double parallel group randomised control trial
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
Placebo 300mg once only and standard of care
干预措施: Placebo (Drug)
Mifepristone and standard of care
Mifepristone 300mg once only and standard of care
干预措施: Mifepristone (Drug)
结局指标
主要结局
Measure of women in labour or delivered within 2 days of intervention
时间窗: up to 2 days after administration of intervention
To determine proportion of women who do not require an induction of labour within 2 days of intervention with mifepristone (superiority).
Measure of women in labour or delivered within 2 days of intervention
时间窗: up to 2 days after administration of intervention
To determine proportion of women who do not require an induction of labour within 2 days of intervention with mifepristone (superiority).
次要结局
- Change in clinical outcomes(up to 6 weeks after delivery)
- Determine whether intervention reduces resource utilisation and patient experience(after delivery and up to 6 weeks after delivery)
- To assess the efficacy and safety of Mifepristone for the outpatient induction of labour(up to 6 weeks after delivery)
- Change in clinical outcomes(up to 6 weeks after delivery)
- Determine whether intervention reduces resource utilisation and patient experience(after delivery and up to 6 weeks after delivery)
- To assess the efficacy and safety of Mifepristone for the outpatient induction of labour(up to 6 weeks after delivery)