Balloon Catheter Versus Propess for Labour Induction
Launched by ST GEORGE'S, UNIVERSITY OF LONDON · Jun 23, 2017
Trial Information
Current as of June 28, 2025
Unknown status
Keywords
ClinConnect Summary
The study will be conducted over two sites: St. George's Hospital in London, and Medway Hospital in Kent. Women requiring induction of labour (IOL) at term will be invited to participate in the study, where they will be randomised to either the trans-cervical balloon catheter or the vaginal prostaglandin 10mg (Propess).
Consent to enter this study will be obtained after 37+0 weeks after a full account has been provided of its nature, purpose, risks, burdens and potential benefits. Patients will have the opportunity to consider whether they wish to take part in the study, up to a maximum of...
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Pregnant women with a single fetus and uncomplicated pregnancy, with a gestational age \> 37+ 0 weeks, needing induction of labour
- • 1. ≥18 years of age
- • 2. No medical risk factors.
- Exclusion Criteria:
- • 1. Out-patient induction of labour is deemed unsuitable for the following women on the grounds of safety -
- • Grand multiparous women (Parity 5 or more)
- • Multiple pregnancy
- • Women with complex medical or obstetric problems (i.e. placenta previa, recurrent antepartum hemorrhage, diabetes, pre-eclampsia, Intrauterine growth restriction (UGR), Obstetric Cholestasis)
- • Previous caesarean section/uterine scar
- • 2. Women who are contracting and/ or requiring analgesia
- • 3. Women who do not fully understand the information leaflet and unable to provide full informed consent
- • 4. Women for whom out-patient induction is unsuitable according to local hospital protocol
About St George's, University Of London
St George's, University of London is a leading academic institution dedicated to advancing healthcare through innovative research and education. As a prominent clinical trial sponsor, the university leverages its expertise in biomedical sciences, medicine, and health professions to conduct rigorous clinical studies aimed at improving patient outcomes. With a commitment to ethical practices and collaboration across disciplines, St George's fosters an environment that encourages groundbreaking discoveries and the translation of research findings into clinical applications, ultimately enhancing the quality of care in diverse medical fields.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Gillingham, Kent, United Kingdom
Tooting, London, United Kingdom
Patients applied
Trial Officials
Amarnath Bhide, MD
Principal Investigator
St. George's University Hospitals Foundation Trust
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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