Mifepristone Outpatient Labour Induction

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chelsea and Westminster NHS Foundation Trust
• Treatments: Mifepristone

Criteria

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 or group B streptococcus carrier, 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