Clinical trial NCT05177510: Mifepristone Outpatient Labour Induction
Official title: Mifepristone Outpatient Labour Induction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Labor, Induced
Lead sponsor: Chelsea and Westminster NHS Foundation Trust
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded parallel group randomised control trial. Intervention arm Mifepristone plus standard care, comparator arm placebo plus standard of care .
Primary purpose: PREVENTION

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 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.

Eligibility criteria: Inclusion Criteria:

1. Pregnant women between 38 and 41+5 weeks of gestation
2. Singleton pregnancy
3. Aged 18 years or older
4. Intact fetal membranes at the time of recruitment
5. Unfavourable cervix (Bishop Score \&lt;6)
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:

1. Multiple pregnancy
2. Breech presentation
3. Early labour
4. 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)
5. Rupture of membranes
6. Parity \&gt;3
7. Clinical evidence of fetal growth restriction
8. Fetal macrosomia (\&gt;95th centile or absolute weight \&gt;4.5kg) based on ultrasound assessment
9. Presence of reduced fetal movements, abnormal CTG or recent antepartum haemorrhage
10. Medical conditions:

    i. anaemia \[\&lt;100g/l\] ii. liver disease iii. pre-existing diabetes\* iv. preeclampsia v. obstetric cholestasis vi. renal disease vii. cardiac disease viii. sexually transmitted infections ix. bleeding disorders, on anticoagulants, steroid or aspirin therapy x. prior uterine operations (Caesarean Section or myomectomy)
11. Contra-indications to mifepristone including chronic adrenal, hepatic, renal failure
12. Hypersensitivity to mifepristone or to any excipients, or malnutrition
13. Severe asthma uncontrolled by therapy and inherited porphyria
14. Any investigational drug within 30 days prior to the trial drug administration. \*NOTE: women with diet controlled gestational diabetes can be included in the trial

Primary outcomes:
measure: Measure of women in labour or delivered within 2 days of intervention
timeFrame: up to 2 days after administration of intervention
Secondary outcomes:
measure: Change in clinical outcomes
timeFrame: up to 6 weeks after delivery
measure: Determine whether intervention reduces resource utilisation and patient experience
timeFrame: after delivery and up to 6 weeks after delivery
measure: To assess the efficacy and safety of Mifepristone for the outpatient induction of labour
timeFrame: up to 6 weeks after delivery
Other outcomes:
Locations:
city: Isleworth
country: United Kingdom
facility: West Middlesex University Hospital
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
Study officials:
affiliation: Chelsea and Westminster NHS Foundation Trust
name: Mark Johnson
role: STUDY_CHAIR
affiliation: Chelsea and Westminster NHS Foundation Trust
name: Damon Foster
role: STUDY_DIRECTOR
References: