Contact information
Type
Scientific
Primary contact
Mr Isaac Tainzana Manyonda
ORCID ID
Contact details
Obstetrics Dept
Lanesborough Wing
St George's Hospital
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
+44 020 8725 3771
i.manyonda@sghms.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0236180646
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2003
Overall trial end date
01/05/2006
Reason abandoned
Lack of funding
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
40 women should be recruited to each group - 80 women in total.
Participant 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.
Recruitment start date
01/11/2003
Recruitment end date
01/05/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Obstetrics Dept
London
SW17 0QT
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
St George's Healthcare NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary