Leave alone or Induce for the Big BabY
| ISRCTN | ISRCTN98146741 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98146741 |
| Protocol serial number | G0000515 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Pilot study for randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Fetal birth trauma (Erbs palsy or any fracture, or neonatal convulsions or intra-cerebral haemorrhage or need for admission to intensive care |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 18/02/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Department of Obstetrics and Gynaecology
Nottingham
NG7 2RD
United Kingdom
NG7 2RD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| 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.
