Mifepristone Outpatient Labour Induction

CW003

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.

2023-08-25

2025-10-09

2026-10-09

Recruiting

Early phase I

400

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.

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2023-09-06