ISRCTN ISRCTN33298015
DOI https://doi.org/10.1186/ISRCTN33298015
Protocol serial number 1
Sponsor King's College London (UK)
Funders Obstetric Anaesthetists Association (UK), Guy's and St Thomas' (GSTT) charity (UK)
Submission date
09/12/2008
Registration date
17/12/2008
Last edited
27/03/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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 information

Primary study designInterventional
Study designRandomised controlled multi-centre trial
Secondary study designRandomised controlled trial
Scientific titleDoes feeding during labour influence the outcome?: a randomised controlled trial
Study acronymFIL
Study objectivesLight 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) studiedLabour/delivery
InterventionLight diet versus water and ice chips. Suggested foods include bread, biscuits, vegetables, fruits, low-fat yoghurt, soup, isotonic drinks and fruit juice.
Intervention typeOther
Primary outcome measure(s)

Spontaneous vaginal delivery.

Key secondary outcome measure(s)

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)

Completion date01/04/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target sample size at registration1126
Key inclusion criteria1. 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 criteria1. Multiparous women
2. <36 weeks' gestation
3. Known maternal or foetal complication
4. Cervical dilatation >5 cm
Date of first enrolment01/06/2001
Date of final enrolment01/04/2006

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Maternal and Foetal Research Unit
London
SE1 7EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing plan

Study outputs

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