Mifepristone Outpatient Labour Induction

Phase 3

Recruiting

• Conditions: Labor, Induced
• Interventions: Drug: Mifepristone; Drug: Placebo

• Registration Number: NCT05177510
• Lead Sponsor: Chelsea and Westminster NHS Foundation Trust

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.

Detailed Description

The study is a double blinded, two arms, multi-centre randomised controlled clinical trial to investigate the clinical effectiveness, safety and resource utilisation of intervention for the induction of labour in low-risk women admitted to the hospital. Subjects will be randomised 1:1 to one of the two arms to receive:

Arm 1: Mifepristone + standard of care Arm 2: Placebo + standard of care

The study treatment will commence from the administration of the Mifepristone or placebo. The participants will be assessed 48 hours after treatment regimen will be completed as an in-patient.

Study Timeline

• Study First Submitted: 2021-11-17
• Study First Submitted QC: 2021-12-15
• Study First Posted: 2022-01-04
• Study Start: 2023-08-25
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-03
• Last Update Posted: 2025-09-10
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

1. Pregnant women between 36+5 and 41+5 weeks of gestation
2. Singleton pregnancy
3. Aged 18 years or older
4. Unfavourable cervix (Bishop Score less than or equal to 6)
5. 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

1. Breech presentation

2. Early labour

3. 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)

4. Fetal growth restriction with oligohydramnios and/or abnormal Dopplers

5. Presence of reduced fetal movements requiring urgent delivery, abnormal CTG or recent antepartum haemorrhage requiring immediate delivery

6. 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)

7. Contra-indications to mifepristone including chronic adrenal, hepatic, renal failure

8. Hypersensitivity to mifepristone or to any excipients, or malnutrition

9. Severe asthma uncontrolled by therapy and inherited porphyria

10. Any investigational drug with an expected interaction with mifepristone which has been administered within 30 days prior to the trial drug administration.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mifepristone and standard of care	Mifepristone	Mifepristone 300mg once only and standard of care
Placebo	Placebo	Placebo 300mg once only and standard of care

Primary Outcome Measures

Name	Time	Method
Measure of women in labour or delivered within 2 days of intervention	up to 2 days after administration of intervention	To determine proportion of women who do not require an induction of labour within 2 days of intervention with mifepristone (superiority).

Secondary Outcome Measures

Name	Time	Method
Change in clinical outcomes	up to 6 weeks after delivery	Occurrence of changes in clinical outcomes such as cervical ripening and interval to delivery.
Determine whether intervention reduces resource utilisation and patient experience	after delivery and up to 6 weeks after delivery	Patient reported outcomes will be collected following administration of questionnaires 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	Incidence and severity of adverse events in maternal and neonatal

Trial Locations

Locations (1)

Chelsea and Westminster Hospital; 🇬🇧 London, United Kingdom