Mifepristone Outpatient Labour Induction

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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 low-risk 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 48 hours after treatment regimen will be completed as an in-patient.

Official Title
-----------------
Mifepristone Outpatient Labour Induction

Conditions
-----------------
Labor, Induced

Intervention / Treatment
-----------------
* Drug: Mifepristone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low risk women (nulliparous and multiparous). Pregnant women between 39 and 41+5 weeks of gestation. Singleton pregnancy. Aged 18 years or older. Intact fetal membranes at the time of recruitment. Unfavourable cervix (Bishop Score <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. Exclusion Criteria: Multiple pregnancy; Breech presentation; Contraindication to vaginal birth placenta praevia, transverse lie, known or suspected cephalo-pelvic disproportion; Rupture of membranes; Parity >3; Clinical evidence of fetal growth restriction, Fetal macrosomia (>95th centile or absolute weight >4.5kg); Presence of reduced fetal movements, abnormal CTG or recent antepartum haemorrhage. Medical conditions: (anaemia [<100g/l], liver disease, diabetes, preeclampsia, obstetric cholestasis, renal disease, cardiac disease, sexually transmitted infections, bleeding disorders, on anticoagulants, steroid or aspirin therapy); prior uterine operations (Caesarean Section or myomectomy) Lives alone, >30 minutes from hospital, no personal transport to hospital. Contra-indications to mifepristone including chronic adrenal, hepatic, renal failure, Hypersensitivity to mifepristone or to any excipients, malnutrition severe asthma uncontrolled by therapy and inherited porphyria. Severe asthma uncontrolled by therapy and inherited porphyria Any investigational drug within 30 days prior to the trial drug administration.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open-label parallel group randomised control trial. One trial Mifepristone plus standard care and placebo plus standard of care comparator arm.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mifepristone and standard of care<br>Mifepristone 300mg once only and standard of care | Drug: Mifepristone<br>* Progestin Antagonist<br>|
| Placebo Comparator: Placebo<br>Placebo 300mg once only and standard of care | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of women in labour or delivered within 48 hours of intervention | To determine proportion of women in established labour (contracting >2/10 minutes with progressive cervical change) or delivered within 48 hours of intervention with Mifepristone (superiority). | up to 48 hours after administration of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinical outcomes | Occurrence of changes in clinical outcomes such as cervical ripening, interval to labour onset and interval to delivery. | up to 6 weeks after delivery | 
| Determine whether intervention reduces resource utilisation and patient experience | Patient reported outcomes will be collected following administration of questionnaires after delivery and up to 6 weeks after delivery | after delivery and up to 6 weeks after delivery | 
| To assess the efficacy and safety of Mifepristone for the outpatient induction of labour | Incidence and severity of adverse events in maternal and neonatal | up to 6 weeks after delivery |