Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT05177510

Mifepristone Outpatient Labour Induction

Led by Chelsea and Westminster NHS Foundation Trust · Updated on 2025-09-10

400

Participants Needed

1

Research Sites

174 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Mifepristone Outpatient Labour Induction

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women between 36 weeks and 5 days and 41 weeks and 5 days of gestation
  • Singleton pregnancy
  • Aged 18 years or older
  • Unfavourable cervix with Bishop Score less than or equal to 6
  • Ability to understand and sign informed consent and willingness to follow all study procedures
Not Eligible

You will not qualify if you...

  • Breech fetal presentation
  • Early labour
  • Contraindications to vaginal birth such as placenta praevia, transverse lie, or suspected cephalo-pelvic disproportion
  • Fetal growth restriction with oligohydramnios or abnormal Dopplers
  • Reduced fetal movements needing urgent delivery, abnormal CTG, or recent antepartum hemorrhage requiring immediate delivery
  • Active sexually transmitted infections
  • Bleeding disorders or current use of anticoagulants, steroids, or aspirin
  • Prior uterine surgery including Caesarean section or myomectomy
  • Contraindications to mifepristone including chronic adrenal, liver, or kidney failure
  • Hypersensitivity to mifepristone or excipients, or malnutrition
  • Severe uncontrolled asthma and inherited porphyria
  • Use of investigational drugs interacting with mifepristone within 30 days prior to trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chelsea and Westminster Hospital

London, United Kingdom

Actively Recruiting

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Research Team

T

Tess Cheetham

CONTACT

A

Arnold Xhikola

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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