Contact information
Type
Scientific
Primary contact
Prof Andrew Shennan
ORCID ID
Contact details
Maternal and Foetal Research Unit
10th Floor North Wing
St Thomas' Hospital
London
SE1 7EH
United Kingdom
+44 (0)20 7188 3640
andrew.shennan@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Does feeding during labour influence the outcome?: a randomised controlled trial
Acronym
FIL
Study hypothesis
Light diet in labour increases the chances of spontaneous vaginal delivery.
Ethics approval
St Thomas' NHS Ethics Committee, approved on 11/10/2000 (ref: EC99/135)
Study design
Randomised controlled multi-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Labour/delivery
Intervention
Light diet versus water and ice chips. Suggested foods include bread, biscuits, vegetables, fruits, low-fat yoghurt, soup, isotonic drinks and fruit juice.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Spontaneous vaginal delivery.
Secondary outcome measures
1. Instrumental vaginal and caesarean section deliveries
2. Need for augmentation
3. Vomiting
4. Neonatal outcomes:
4.1. Apgar scores
4.2. Admission to neonatal intensive care unit (NICU)/ special care baby unit (SCBU)
Overall trial start date
01/06/2001
Overall trial end date
01/04/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Females, no age limits
2. Primiparous women >36 weeks gestation
3. Singleton pregnancies
4. No maternal or foetal complications
5. Cervical dilatation less than or equal to 5 cm
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1,126
Participant exclusion criteria
1. Multiparous women
2. <36 weeks' gestation
3. Known maternal or foetal complication
4. Cervical dilatation >5 cm
Recruitment start date
01/06/2001
Recruitment end date
01/04/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Maternal and Foetal Research Unit
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Conybeare House
Guy's Hospital
London
SE1 7EH
United Kingdom
+44 (0)20 7848 6960
keith.brennan@kcl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Obstetric Anaesthetists Association (UK)
Alternative name(s)
OAA
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United Kingdom
Funder name
Guy's and St Thomas' (GSTT) charity (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19318702
Publication citations
-
Results
O'Sullivan G, Liu B, Hart D, Seed P, Shennan A, Effect of food intake during labour on obstetric outcome: randomised controlled trial., BMJ, 2009, 338, b784.