Novel extended balloon labour induction/augmentation (EBLIA) device to improve safety of labour induction: preliminary clinical study
Pregnant participants due for labour induction
Preliminary proof-of-concept clinical trial: The initial trial is designed to assess essential safety, performance, feasibility and acceptability and to give an indication of effectiveness and suitability for a substantive randomized effectiveness trial. It will include a small number of low-risk participants (n = 30). As a benchmark against which to judge the outcomes and to establish the feasibility of a future formal randomized trial, a randomly allocated ‘usual care’ control group will be included (Foley catheter balloon labour induction). In view of the small numbers, formal statistical comparisons will not be performed. Following the required ethical and regulatory approvals, participants who meet the inclusion criteria and consent to participate will be allocated by randomly ordered opaque sealed envelopes to undergo labour induction using the EBLIA balloon or the standard Foley balloon. Allocation will be in a computer-generated random sequence in variable balanced blocks of 4-6 concealed in consecutively numbered opaque sealed envelopes. Participants will receive routine monitoring and care and will be followed up until discharge from hospital. Participants and providers will complete structured and open-ended questionnaires to document acceptability, ease of the procedure, discomfort, and satisfaction. Baseline demography and clinical data will be recorded. EBLIA procedure: Participants will be fully counselled about the procedure. Sterile procedures will be followed as for routine labour induction with a Foley catheter balloon. The EBLIA balloon will be inserted transcervically. The uterine balloon will be inflated with sterile saline from an infusion set 1.3 m above the participant (100 mmHg). The cervical balloon will be inflated with an infusion set gradually raised to a level which does not cause participant discomfort (0-50 mmHg). Control: For the control group, routine Foley labour induction will be performed according to hospital policies. The f
1. Age >18 years 2. Planned labour induction 3. Singleton cephalic pregnancy 4. Gestation 36 weeks or more 5. Suitable for balloon labour induction 6. Informed consent
Major medical complications such as cardiac disease, diabetes, severe pre-eclampsia