Mifepristone Outpatient Labour Induction (MOLI)

Chelsea and Westminster NHS Foundation Trust

Status and phase: Enrolling; Phase 2

Conditions: Labor, Induced

Treatments: Drug: Placebo; Drug: Mifepristone

Study type: Interventional

Funder types: Other

Identifiers

NCT05177510

CW003

2021-004860-93 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 <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 >3

7. Clinical evidence of fetal growth restriction

8. Fetal macrosomia (>95th centile or absolute weight >4.5kg) based on ultrasound assessment

9. Presence of reduced fetal movements, abnormal CTG or recent antepartum haemorrhage

10. Medical conditions:

    i. anaemia [<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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

Mifepristone and standard of care

Experimental group

Description:

Mifepristone 300mg once only and standard of care

Treatment:

Drug: Mifepristone

Placebo

Placebo Comparator group

Description:

Placebo 300mg once only and standard of care

Treatment:

Drug: Placebo