None listed
Conditions
Brief summary
Aims of study are 1) To compare: a) Clinical effectiveness b) Patient acceptability c) Safety of the use of Foley catheter in the outpatient setting with intravaginal PGE2 (Prostin) gel in the inpatient setting for induction of labour. 2) To assess the cost-effectiveness of intracervical Foley catheter in the outpatient setting to intravaginal PGE2 (Prostin) gel in the inpatient setting for use in induction of labour. The hypothesis is that for induction of labour in women with an unfavourable cervix, use of the catheter on an outpatient basis (women have catheter inserted, then go home until the following morning) will be at least as clinically effective and safe as use of gel as an inpatient (staying in hospital), and that outpatient catheter use will be both acceptable to women and cost-effective. Currently, most pregnant women who need cervical ripening as part of an induction of labour stay in hospital from the time the gel or catheter is inserted until the cervix is ready for the rest of the induction. This means many women stay 12-24 hours in hospital while they are not in labour, but are waiting for the gel or catheter to work. Most women and their babies needing cervical ripening are otherwise very well, and could stay at home during this time if a safe and effective way to do this was available.
Interventions
Foley catheter placed intracervically (with 30mL inflation of balloon) in women requiring cervical ripening procedure as part of induction of labour. Catheter placement procedure takes approximately 5 minutes. Women then return home while cervical ripening occurs (expected duration of catheter in situ 12-18 hours, maximum 24 hours) and return to hospital for induction the following day.
Sponsors
Royal Hospital for Women
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Age 18 and over Gestational age 37 weeks or greater Booked for cervical ripening procedure as part of induction of labour
Exclusion criteria
Not suitable for outpatient management on maternal or fetal grounds Potentially unsuitable for randomisation to prostaglandin gel use (e.g. uterine scar, oligohydramnios, grand multiparity) Bishop's score 7 or more, or cervical dilation 2cm or greater, at time of booked induction Regular painful uterine contractions at time of booked induction Ruptured membranes Chorioamnionitis or suspected chorioamnionitis Multiple pregnancy Non-vertex presentation Non-English speaking Allergy/hypersensitivity to Latex or PGE2 gel
Outcome results
None listed