Using Mifepristone for outpatient labor induction
Mifepristone Outpatient Labour Induction
This study tests if using Mifepristone can safely help pregnant women start labor at home instead of in the hospital.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Chelsea and Westminster NHS Foundation Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05177510 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 and older, between 38 and 41+5 weeks of gestation, with a singleton pregnancy and an unfavorable cervix.
Not a fit: Patients with multiple pregnancies, breech presentations, or contraindications to vaginal birth will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to fewer hospital admissions and a better overall experience for women undergoing labor induction.
How similar studies have performed: Other studies have explored labor induction methods, but the use of Mifepristone in this outpatient setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
London
- Chelsea and Westminster Hospital — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Tess Cheetham
- Email: tess.cheetham@nhs.net
- Phone: +442033156825
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.