Overview

Balloon Catheter Versus Propess for Labour Induction

Status:
Unknown status
Trial end date:
2019-05-31
Target enrollment:
0
Participant gender:
Female
Summary
This study will randomise low-risk women to compare the effectiveness of trans-cervical balloon catheter for pre-induction cervical ripening for out-patient induction of labour with current practice (Propess). Women will be randomised to two treatment groups. The investigators wish to explore if such a trial is feasible, acceptable to women and what data collection is required for a future trial. Since no data exist, the investigators propose a study with approximately 60 women in each arm across two recruiting sites.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
St George's, University of London
Collaborators:
City University, London, United Kingdom
City, University of London
King's Clinical Trials Unit, London, United Kingdom
Medway University Hospital, United Kingdom
Treatments:
Dinoprostone
Criteria
Inclusion Criteria:

Pregnant women with a single fetus and uncomplicated pregnancy, with a gestational age >
37+ 0 weeks, needing induction of labour

1. ≥18 years of age

2. No medical risk factors.

Exclusion Criteria:

1. Out-patient induction of labour is deemed unsuitable for the following women on the
grounds of safety -

- Grand multiparous women (Parity 5 or more)

- Multiple pregnancy

- Women with complex medical or obstetric problems (i.e. placenta previa, recurrent
antepartum hemorrhage, diabetes, pre-eclampsia, Intrauterine growth restriction
(UGR), Obstetric Cholestasis)

- Previous caesarean section/uterine scar

2. Women who are contracting and/ or requiring analgesia

3. Women who do not fully understand the information leaflet and unable to provide full
informed consent

4. Women for whom out-patient induction is unsuitable according to local hospital
protocol