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