Using Mifepristone for outpatient labor induction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness and safety of Mifepristone for inducing labor in pregnant women, aiming to reduce hospital admissions and improve the birthing experience. It is a double-blinded, two-arm, multi-centre randomized controlled trial where participants will receive either Mifepristone combined with standard care or a placebo with standard care. The study will assess outcomes two days after treatment to evaluate the intervention's impact on labor induction. The goal is to provide a safer and more acceptable outpatient option for women needing labor induction.

Why it matters

Who can join: the full rules

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.

Where it's running

• Chelsea and Westminster Hospital
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: Tess Cheetham
• Email: tess.cheetham@nhs.net
• Phone: +442033156825

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.