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 |
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DOI | https://doi.org/10.1186/ISRCTN39708525 |
Secondary identifying numbers | N0236180646 |
- 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
Scientific
Obstetrics Dept
Lanesborough Wing
St George's Hospital
Blackshaw Road, Tooting
London
SW17 0QT
United Kingdom
Phone | +44 020 8725 3771 |
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i.manyonda@sghms.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | 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 study start date | 01/11/2003 |
Completion date | 01/05/2006 |
Reason abandoned (if study stopped) | Lack of funding |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 40 women should be recruited to each group - 80 women in total. |
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
- England
- United Kingdom
Study participating centre
Obstetrics Dept
London
SW17 0QT
United Kingdom
SW17 0QT
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
St George's Healthcare NHS Trust (UK)
No information available
NHS R&D Support Funding
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |