ClinConnect ClinConnect Logo
Search / Trial NCT03199820

Balloon Catheter Versus Propess for Labour Induction

Launched by ST GEORGE'S, UNIVERSITY OF LONDON · Jun 23, 2017

Trial Information

Current as of June 04, 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.

Locations

Gillingham, Kent, United Kingdom

Tooting, London, United Kingdom

Patients applied

0 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

Similar Trials