Mifepristone Outpatient Labour Induction

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorChelsea and Westminster NHS Foundation Trust

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Mifepristone
  • Placebo

Treatment groups

400 Participants
are divided into 2 treatment groups