Condition category
Pregnancy and Childbirth
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
28/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes