Does feeding during labour influence the outcome?

ISRCTN	ISRCTN33298015
DOI	https://doi.org/10.1186/ISRCTN33298015
Secondary identifying numbers	1

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Andrew Shennan
Scientific

Maternal and Foetal Research Unit
10th Floor North Wing
St Thomas' Hospital
London
SE1 7EH
United Kingdom

Phone	+44 (0)20 7188 3640
Email	andrew.shennan@kcl.ac.uk

Study design	Randomised controlled multi-centre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Other
Scientific title	Does feeding during labour influence the outcome?: a randomised controlled trial
Study acronym	FIL
Study objectives	Light diet in labour increases the chances of spontaneous vaginal delivery.
Ethics approval(s)	St Thomas' NHS Ethics Committee, approved on 11/10/2000 (ref: EC99/135)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/06/2001
Completion date	01/04/2006

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	1,126
Key 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
Key exclusion criteria	1. Multiparous women 2. <36 weeks' gestation 3. Known maternal or foetal complication 4. Cervical dilatation >5 cm
Date of first enrolment	01/06/2001
Date of final enrolment	01/04/2006

Maternal and Foetal Research Unit

London
SE1 7EH
United Kingdom

King's College London (UK)
University/education

Conybeare House
Guy's Hospital
London
SE1 7EH
England
United Kingdom

Charity

Obstetric Anaesthetists Association (UK)
Private sector organisation / Associations and societies (private and public)

Guy's and St Thomas' (GSTT) charity (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Guy's and St Thomas' Charity, Guy's and St Thomas' Foundation, GSTTFoundation
Location: United Kingdom

Intention to publish date
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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	24/03/2009		Yes	No