Leave alone or Induce for the Big BabY
| ISRCTN | ISRCTN98146741 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98146741 |
| Secondary identifying numbers | G0000515 |
- Submission date
- 21/09/2000
- Registration date
- 21/09/2000
- Last edited
- 27/09/2017
- 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
Mr James G Thornton
Scientific
Scientific
Department of Obstetrics and Gynaecology
The University of Nottingham University Park
Nottingham
NG7 2RD
United Kingdom
Study information
| Study design | Pilot study for randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Leave alone or Induce for the Big BabY: a randomised controlled trial |
| Study acronym | LIBBY |
| Study objectives | Does induction of labour for suspected fetal macrosomia confer maternal or fetal benefits? |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Suspected fetal macrosomia |
| Intervention | Not provided at time of registration. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 26/07/1999 |
| Completion date | 18/02/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 72 in each group (total = 144) |
| Key inclusion criteria | Not provided at time of registration. |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 26/07/1999 |
| Date of final enrolment | 18/02/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Obstetrics and Gynaecology
Nottingham
NG7 2RD
United Kingdom
NG7 2RD
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| 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 | 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | pilot results within Cochrane Review | 01/08/2000 | Yes | No |
Editorial Notes
27/09/2017: publication status clarified.
