Prostaglandin Insert (Propess) Versus Trans-cervical Balloon Catheter for Out-patient Labour Induction: A Randomised Controlled Trial of Feasibility

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 72 hours. For prolonged pregnancy (41+0 weeks), Induction of labour is generally booked at 41+3 weeks, giving a 3-day time period to think about participation. Periods shorter than 72 hours will be permitted if the woman felt that further deliberation will not lead to a change in her decision, and provided the person seeking consent is satisfied that the woman has fully retained, understood and deliberated on the information given. This provision has been made with the support of our patient advisory group. Likewise, periods longer than 72 hours will be permitted should the woman request this. The Investigator or designee will explain that the women are under no obligation to enter the trial and that they can withdraw at any time during the trial, without having to give a reason. A copy of the signed Informed Consent Form will be given to the study participant. The original signed consent form (ICF) will be retained at the study site in the Investigation site file (ISF) and a copy of the ICF along with a copy of the Participant Information Sheet (PIS) will be retained in the maternity notes.

If new safety information results in significant changes to the risk-benefit assessment, the consent form will be reviewed and updated if necessary. All subjects, including those already treated, will be informed of the new information, given a copy of the revised consent form and asked to re-consent if they choose to continue in the study.

In order to ensure a similar distribution between treatment groups in important characteristics thought to affect outcomes, including site and parity, allocation will be random and stratified by site (St. George's and Medway) and parity (nulliparous and multiparous). Participants will be allocated using block randomisation so as to ensure similar numbers of participants in the treatment groups. Whilst blocks of size four are proposed, advice regarding random block sizes (including four, six and eight) will be sought from the Kings Clinical Trials Unit (CTU).

Participants and midwives will not be blinded to the treatment allocation. The trial statistician will be blinded to group allocation.