Mifepristone Outpatient Labour Induction

NCT05177510 | Recruiting Phase 2 DMC

• 2 other identifiers: CW0032021-004860-93
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor, Induced

Outcome Measures

Primary Outcomes (1)

• Measure of women in labour or delivered within 2 days of intervention

  To determine proportion of women who do not require an induction of labour within 2 days of intervention with mifepristone (superiority).

  up to 2 days after administration of intervention

Secondary Outcomes (3)

• Change in clinical outcomes

  up to 6 weeks after delivery

• Determine whether intervention reduces resource utilisation and patient experience

  after delivery and up to 6 weeks after delivery

• To assess the efficacy and safety of Mifepristone for the outpatient induction of labour

  up to 6 weeks after delivery

Study Arms (2)

Mifepristone and standard of care

EXPERIMENTAL

Mifepristone 300mg once only and standard of care

Drug: Mifepristone

Placebo

PLACEBO COMPARATOR

Placebo 300mg once only and standard of care

Drug: Placebo

Interventions

Mifepristone DRUG

Progestin Antagonist

Mifepristone and standard of care

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women between 36+5 and 41+5 weeks of gestation.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead

Study Sites (1)

Chelsea and Westminster Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Interventions

Mifepristone

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mark Johnson

  Chelsea and Westminster NHS Foundation Trust

  STUDY CHAIR

• Damon Foster

  Chelsea and Westminster NHS Foundation Trust

  STUDY DIRECTOR

Central Study Contacts

Tess Cheetham

CONTACT

+442033156825; tess.cheetham@nhs.net

Arnold Xhikola

CONTACT

+442033156825; arnold.xhikola@nhs.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double parallel group randomised control trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded parallel group randomised control trial. Intervention arm Mifepristone plus standard care, comparator arm placebo plus standard of care .

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: January 4, 2022
• Study Start: August 25, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)