Mifepristone Outpatient Labour Induction

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Labor, Induced

In brief

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.

Key facts

Study ID

NCT05177510

Run by

Chelsea and Westminster NHS Foundation Trust

People needed

400

Starts

2023-08-25

Expected to finish

2026-12-31

Last updated by the study team

2025-09-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Chelsea and Westminster Hospital — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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