Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G0000515
Study information
Scientific title
Leave alone or Induce for the Big BabY: a randomised controlled trial
Acronym
LIBBY
Study hypothesis
Does induction of labour for suspected fetal macrosomia confer maternal or fetal benefits?
Ethics approval
Not provided at time of registration.
Study design
Pilot study for randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Suspected fetal macrosomia
Intervention
Not provided at time of registration.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Fetal birth trauma (Erbs palsy or any fracture, or neonatal convulsions or intra-cerebral haemorrhage or need for admission to intensive care
2. Instrumental vaginal delivery
3. Caesarean section
4. Maternal injury
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
26/07/1999
Overall trial end date
18/02/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
72 in each group (total = 144)
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
26/07/1999
Recruitment end date
18/02/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Obstetrics and Gynaecology
Nottingham
NG7 2RD
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Added 27/09/17: This was a pilot study. The results were given to the Cochrane reviewers and included in the relevant Cochrane Review (see publication summary section). No other publication plans.
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2000 pilot results within Cochrane Review in: https://www.ncbi.nlm.nih.gov/pubmed/10796221
Publication citations
-
Pilot results within Cochrane Review
Irion O, Boulvain M, Induction of labour for suspected fetal macrosomia., Cochrane Database Syst Rev, 2000, 2, CD000938, doi: 10.1002/14651858.CD000938.