Title: Trans-cervical balloon catheter and its comparison to sustained release prostaglandin use for out-patient induction of labour in low-risk women: A feasibility study for a randomised controlled trial.
Funder: Department of Health and Social Care

Abstract: Background: Induction of labour is a common intervention. The most common method for induction of labour is use of vaginal prostaglandins as a tablet or a sustained release suppository (Propess). Transcervical balloon catheter is an alternative. The method of induction of labour may have implications for efficacy, safety, maternal satisfaction and costs. We propose to determine if the induction of labour using a trans-cervical balloon catheter (Cook balloon) is acceptable to pregnant women as compared to labour induction utilising sustained release Prostaglandin (Propess) in the outpatient setting. A randomised controlled trial is the ideal study design. The current study is a feasibility study to assess the acceptability of the intervention and of randomisation to women, and what core outcome data can be collected. The study will give an estimate of recruitment numbers and time over which the recruitment will need to be carried out for a future trial. Methods: Following informed consent pregnant women with a singleton pregnancy attending for induction of labour for prolonged pregnancy (41+0 weeks or over) will be asked if they are willing to be randomised to a method of labour induction. Participants will be assigned at random to the trans-cervical ripening balloon catheter or vaginal prostaglandin 10mg (Propess) in the outpatient setting. We will obtain a fetal heart tracing (CTG) after insertion of Propess/cervical balloon catheter. Women will be allowed to go home if the post-insertion CTG was normal. Manufacturer’s’ recommendations are to allow the insertion of Propess to act for 24 hours. Therefore, women with Propess®(and those with trans-cervical balloon catheter) will be asked to return to the hospital if in labour, or next morning at 07:00h, whichever is earlier. Women’s views about the acceptability of each method will be evaluated via survey and qualitative methods. Primary objective: To ascertain if 1) Women are willing to be randomised to a method of labour induction in an outpatient setting 2) If women have a preference for a method of induction of labour, their willingness to participate in a randomised trial 3) Women’s experience of the labour induction process. Data will also be gathered on clinical outcomes including mode of birth, rate of labour and birth complications, admission to NNU, maternal and infant morbidity. Economic Evaluation This feasibility trial will explore and model the measures needed to enable a full economic evaluation (cost consequences or cost-effectiveness) in a future RCT and test availability of necessary data. Data to be collected include: time in the unit before return to home, numbers of phone or personal calls to the unit, rate of re-admissions prior to diagnosis of active labour, time from readmission to birth, time from admission to postnatal hospital discharge, number of further Propess administrations, and rate of use of additional induction methods. Summary of the potential benefits to patients and the NHS: The potential benefits of trans-cervical balloon catheter induction to the patient are: 1. No drugs used and the risk of excessive uterine stimulation is eliminated leading to better safety. 2. Hyperstimulation does not occur with trans-cervical balloon use leading to lesser use of pain-relief. 3. Lesser risk for the fetus getting distressed. 4. A lower chance of unscheduled hospital visit in the middle of the night. The potential benefits to the NHS are: 1. Mechanical methods may be cheaper because of reduced complication rate. 2. A higher proportion of women in the transcervical balloon catheter group staying out of the hospital for the night than that with Prostaglandins. 3. Potential benefits in terms of women's experience of labour, with further wellbeing implications 4. Cost-savings in terms of staff time, bed use and unscheduled admissions.

Lay abstract: 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. Both the catheter or Propess are removed after 18-24 hours, and waters are broken to start the process of labour. The catheter is an equally effective but possibly safer and cheaper alternative to Propess which 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, whether women are willing to be allocated at random to Propess or catheter, and explore their experiences. This data will help us to assess the feasibility and design of a larger future trial. We are doing this research with patient representatives. We will communicate the findings of the research to midwives and doctors, general public including pregnant women, user groups, funding bodies, and healthcare planners.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH