Mifepristone Outpatient Labour Induction

Labor, Induced Clinical Trial

— MOLI  

Official title:

Mifepristone Outpatient Labour Induction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05177510
• Other study ID #: CW003
• Secondary ID: 2021-004860-93
• Status: Recruiting
• Phase: Phase 3
• Start date: August 25, 2023
• Est. completion date: October 9, 2026

Study information

• Verified date: August 2023
• Source: Chelsea and Westminster NHS Foundation Trust
• Contact: Tess Cheetham
• Phone: 020 331 56825
• Email: tess.cheetham[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 9, 2026
• Est. primary completion date: October 9, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Low risk women (nulliparous and multiparous).
• Pregnant women between 39 and 41+5 weeks of gestation.
• Singleton pregnancy.
• Aged 18 years or older.
• Intact fetal membranes at the time of recruitment.
• Unfavourable cervix (Bishop Score <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.

Exclusion Criteria:

• Multiple pregnancy;
• Breech presentation;
• Contraindication to vaginal birth placenta praevia, transverse lie, known or suspected cephalo-pelvic disproportion;
• Rupture of membranes;
• Parity >3;
• Clinical evidence of fetal growth restriction,
• Fetal macrosomia (>95th centile or absolute weight >4.5kg);
• Presence of reduced fetal movements, abnormal CTG or recent antepartum haemorrhage.
• Medical conditions: (anaemia [<100g/l], liver disease, diabetes, preeclampsia, obstetric cholestasis, renal disease, cardiac disease, sexually transmitted infections, bleeding disorders, on anticoagulants, steroid or aspirin therapy); prior uterine operations (Caesarean Section or myomectomy)
• Lives alone, >30 minutes from hospital, no personal transport to hospital.
• Contra-indications to mifepristone including chronic adrenal, hepatic, renal failure,
• Hypersensitivity to mifepristone or to any excipients, malnutrition severe asthma uncontrolled by therapy and inherited porphyria.
• Severe asthma uncontrolled by therapy and inherited porphyria
• Any investigational drug within 30 days prior to the trial drug administration.

Related Conditions & MeSH terms

• Labor, Induced

Intervention

Drug:
• Mifepristone
Progestin Antagonist
• Placebo
Placebo

Locations

Country	Name	City	State
United Kingdom	West Middlesex University Hospital	Isleworth
United Kingdom	Chelsea and Westminster Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Chelsea and Westminster NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of women in labour or delivered within 48 hours of intervention	To determine proportion of women in established labour (contracting >2/10 minutes with progressive cervical change) or delivered within 48 hours of intervention with Mifepristone (superiority).	up to 48 hours after administration of intervention
Secondary	Change in clinical outcomes	Occurrence of changes in clinical outcomes such as cervical ripening, interval to labour onset and interval to delivery.	up to 6 weeks after delivery
Secondary	Determine whether intervention reduces resource utilisation and patient experience	Patient reported outcomes will be collected following administration of questionnaires after delivery and up to 6 weeks after delivery	after delivery and up to 6 weeks after delivery
Secondary	To assess the efficacy and safety of Mifepristone for the outpatient induction of labour	Incidence and severity of adverse events in maternal and neonatal	up to 6 weeks after delivery