Condition category
Pregnancy and Childbirth
Date applied
21/09/2000
Date assigned
21/09/2000
Last edited
17/05/2011
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

Professor James G Thornton

ORCID ID

Contact details

Department of Obstetrics and Gynaecology
The University of Nottingham University Park
Nottingham
NG7 2RD
United Kingdom
+44 (0)115 951 5151

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0000515

Study information

Scientific title

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

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

2000 pilot results within http://www.ncbi.nlm.nih.gov/pubmed/10796221

Publication citations

  1. Pilot results within

    Irion O, Boulvain M, Induction of labour for suspected fetal macrosomia., Cochrane Database Syst Rev, 2000, 2, CD000938, doi: 10.1002/14651858.CD000938.

Additional files

Editorial Notes