Foley Catheter Latex versus Silicone for Cervical Ripening Prior to Term Induction of Labour: a randomized controlled trial

Women 16 years and over, booked for cervical ripening with a Foley catheter for term induction of labour will be randomised to either 18F latex Foley catheter or 18F silicone Foley catheter, to compare the incidence of inadvertent membrane rupture and effectiveness of cervical ripening

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000795594

Enrollment

534

Registered

2015-07-31

Start date

2015-05-01

Completion date

2017-07-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Foley catheters have long been used to ripen (soften, shorten and dilate) the cervix prior to induction of labour. Two catheter materials are widely available – latex and silicone. There is currently no evidence to guide practitioners as to which is preferable for cervical ripening with respect to ease of insertion, efficacy in ripening and safety for baby and mother. The primary aim of this study is to determine if there is a difference in outcomes between the two types of catheter used latex and silicone. The primary outcome is inadvertent rupture of membranes. Secondary outcomes include: 1. Maternal discomfort at insertion 2. Inserter assessment of ease of insertion 3. Duration of time before catheter falls out 4. Labour outcomes including: Mode of delivery, Duration of labour 5. Maternal labour complications including: Maternal fever, Antiobiotic administration for suspected chorioamnionitis, Maternal blood loss at delivery 6. Neonatal outcomes including: Apgar scores, Umbilical artery cord lactate, admission to neonatal nursery 7. Foley catheter insertion failure The study is a prospective randomized clinical trial to be carried out at Westmead Hospital in the Day Assessment Unit and the Birth Unit (the usual sites of Foley catheter insertion). Apart from the randomization of catheter material (latex v silicone) all other care will be identical to women not participating in the study.All women 16 years and over booked for cervical ripening with a Foley catheter before term induction of labour will be asked to participate in the study.

Interventions

1. 18F 30mL Latex Foley Catheter - Used for cervical ripening in induction of labour - Will be administered in Day Assessment Unit by trained O&G medical and midwifery staff - Will be used from time of insertion until catheter falls out or is removed at time of artificial rupture of membranes for commencement of induction of labour - Foleys catheter usage will be checked by staff inserting foleys & 1x other member of staff

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

16 Years to 45 Years

Healthy volunteers

Inclusion criteria

All women 16 years and over booked for cervical ripening with a Foley catheter before term induction of labour will be asked to participate in the study. Those who decline participation will have a Foley catheter material of the obstetrician’s choosing.

Exclusion criteria

1. Latex allergy 2. Bishop score greater than 7 3. Ruptured membranes 4. Placenta closer than 2cm from internal os or undiagnosed vaginal bleeding 5. Abnormal pre-ripening CTG 6. Prior use of prostaglandin gel or Foley catheter for ripening in the current pregnancy 7. Active or purulent infection of the lower genital tract 8. Lethal congenital anomaly or fetal demise 9. Age less than 16 years 10. Unable to consent

Outcome results