Labor, Induced
Conditions
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.
Interventions
DRUGMifepristone
Progestin Antagonist
DRUGPlacebo
Placebo
Sponsors
Chelsea and Westminster NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This is a double parallel group randomised control trial
Intervention model description
Double-blinded parallel group randomised control trial. Intervention arm Mifepristone plus standard care, comparator arm placebo plus standard of care .
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United Kingdom
Contacts
CONTACTTess Cheetham
CONTACTArnold Xhikola
STUDY_CHAIRMark Johnson
Chelsea and Westminster NHS Foundation Trust
STUDY_DIRECTORDamon Foster
Chelsea and Westminster NHS Foundation Trust
Outcome results
None listed