A randomised controlled trial of the use of the Foley catheter balloon for induction of labour to reduce the incidence of caesarean section in diabetic pregnancies: a prospective clinical, economic and psychological evaluation

ISRCTN	ISRCTN39708525
DOI	https://doi.org/10.1186/ISRCTN39708525
Protocol serial number	N0236180646
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funders	St George's Healthcare NHS Trust (UK), NHS R&D Support Funding

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 28/09/2011

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Isaac Tainzana Manyonda
Scientific

Obstetrics Dept
Lanesborough Wing
St George's Hospital
Blackshaw Road, Tooting
London
SW17 0QT
United Kingdom

Phone	+44 020 8725 3771
Email	i.manyonda@sghms.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	1. To establish if Foley catheter balloon cervical dilatation can improve the rates of successful induction of labour in insulin-dependent pregnant diabetic women, and thereby reduce caesarean section rates. 2. To establish whether there is an increase in satisfaction with labour and outcome in women who undergo this new method of inducing labour. 3. To establish whether there are any economic advantages to this new method of induction of labour
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Pregnancy and Childbirth: Labour induction
Intervention	Women consenting to participate in the trial will be randomly allocated to one of two groups: 1. Women will be induced at 38 weeks gestation by means of vaginal prostaglandins according to our current labour ward protocol. 2. 24 hrs before planned induction of labour, a Foley balloon catheter will be inserted through the cervical canal and inflated to 30ml, and left in situ for 24 hrs, or until it drops out when the cervix has dilated to 4cm+, which ever occurs earlier. Labour is then induced as per protocol used in women in group 1.
Intervention type	Other
Primary outcome measure(s)	Vaginal delivery versus caesarean section. 1. Clinical: induction success rates, caesarean section rates, length of labour, instrumental delivery, blood loss and neonatal outcomes including Apgar scores, admission to SCBU and blood glucose levels. 2. Psychological: maternal satisfaction rates assessed by a designer questionnaire. 3. Economic: basic costs assessment, including the costs of Foley catheters, additional 24 hour hospital stay, costs of caesarean section etc.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/05/2006
Reason abandoned (if study stopped)	Lack of funding

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	80
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Women will be excluded if they are planning an elective caesarean delivery, are multiparae, have co-existing other medical disorders, multiple pregnancy, breech or any presentation other than cephalic.
Date of first enrolment	01/11/2003
Date of final enrolment	01/05/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Obstetrics Dept

London
SW17 0QT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan