Condition category
Pregnancy and Childbirth
Date applied
09/12/2008
Date assigned
17/12/2008
Last edited
27/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.kcl.ac.uk

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

  1. 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.

Additional files

Editorial Notes