NCT05177510

Mifepristone Outpatient Labour Induction

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Chelsea and Westminster NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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 2 days after treatment regimen will be completed as an in-patient.

Conditions

• Labor, Induced

Interventions

Type	Name	Description
DRUG	Mifepristone	Progestin Antagonist
DRUG	Placebo	Placebo

Timeline

• Start date: 2023-08-25
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-01-04
• Last updated: 2025-09-10

Locations

1 site across 1 country: United Kingdom