Trans-cervical balloon catheter and prostaglandin for labour induction
Research type
Research Study
Full title
Prostaglandin insert (Propess) versus tran-scervical balloon catheter for out-patient labour induction: A randomised controlled trial of feasibility (PROBIT-F)
IRAS ID
212856
Contact name
Amarnath Bhide
Contact email
Sponsor organisation
St George's University Hospitals NHS Foundation Trust
Eudract number
2017-001914-27
Duration of Study in the UK
1 years, 10 months, 28 days
Research summary
Labour is a natural process, but sometimes it needs to be started artificially
(Induction of labour). Currently, two methods of induction are used. The
aim of this project is to compare how well these methods of labour
induction work, which is the safest and least expensive method, and which
is more acceptable to and favoured by women.
The first method is PGE2 (synthetic prostaglandin), administered as a
pessary (Propess) introduced in the vagina that delivers prostaglandin over
24 hours. The drug acts by softening the neck of the womb (cervix). Side effects include commencement of labour pains (contractions), which can
sometimes be too frequent/strong and may be harmful to the baby and/or
mother. The second less commonly used method is a catheter - a soft
rubber tube with an inflatable balloon at the tip. The balloon is placed in the
cervix, and softens it by causing the release of natural hormones
(prostaglandins) produced by the woman's body. Excessive contractions
have not been reported with catheter use.
The catheter is an equally effective (but possibly safer and cheaper
alternative to Propess) and is currently underutilised; and its use in the
outpatient setting deserves further exploration. In this study, we want to
find out if the balloon catheter is acceptable to women for labour induction
as an out-patient, and furthermore whether women are willing to be allocated at random to Propess or the catheter, and explore their experiences. This data will help us to assess the feasibility and design of a larger future trial.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
17/EE/0295
Date of REC Opinion
24 Aug 2017
REC opinion
Further Information Favourable Opinion