Mifepristone Outpatient Labour Induction

Launched by CHELSEA AND WESTMINSTER NHS FOUNDATION TRUST · Dec 15, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Mifepristone, which is being tested as a new way to induce labor for pregnant women. Currently, many women have to go to the hospital for labor induction, which can be uncomfortable and costly. This trial aims to see if Mifepristone can safely and effectively allow women to start labor at home, reducing the need for hospital stays and making the experience better for everyone involved.

To be eligible for the trial, women must be between 38 and 41 weeks pregnant, have a single baby, and be at least 18 years old. They also need to have a specific type of cervix (one that is not ready for labor) and must be able to understand and sign a consent form. Participants will receive Mifepristone and will be monitored to ensure their safety and the effectiveness of the medication. This study is especially important as it may help reduce hospital visits during a time when pregnant women are at higher risk for COVID-19.

Gender

FEMALE

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 \<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