Overview of the Role of Antibiotics in Curtailing Labour and Early delivery
| ISRCTN | ISRCTN53994660 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53994660 |
| Secondary identifying numbers | G9226450 |
- Submission date
- 25/10/2000
- Registration date
- 25/10/2000
- Last edited
- 05/07/2018
- 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
Not provided at time of registration
Contact information
Dr Robin Youngs
Scientific
Scientific
Department of Obstetrics & Gynaecology
Clinical Sciences Building
Leicester Royal Infirmary
Gloucester
GL1 3NN
United Kingdom
| Phone | +441452394205 |
|---|---|
| abc@123.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | Overview of the Role of Antibiotics in Curtailing Labour and Early delivery (ORACLE) |
| Study acronym | ORACLE |
| Study hypothesis | The ORACLE trial is designed to test the hypothesis that treatment of women with idiopathic preterm labour or preterm rupture of the membranes (PROM) with broad spectrum antibiotics reduces neonatal mortality and morbidity due to preterm birth |
| Ethics approval(s) | Added 18/07/2007: Approved by West Midlands Multicentre Research Ethics Committee. |
| Condition | Obstetrics and gynaecology |
| Intervention | Broad spectrum antibiotics/placebo |
| Intervention type | Other |
| Primary outcome measure | Neonatal death, Chronic lung disease, Major cerebral pathology |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/07/1994 |
| Overall study end date | 31/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 10000 |
| Participant inclusion criteria | Pregnant women less than 37 weeks gestation either in preterm labour or with premature rupture of membranes (PROM) |
| Participant exclusion criteria | Need for immediate delivery, contraindications for antibiotics |
| Recruitment start date | 01/07/1994 |
| Recruitment end date | 31/03/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Obstetrics & Gynaecology
Leicester
LE2 7LX
United Kingdom
LE2 7LX
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 | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | ORACLE I results | 31/03/2001 | Yes | No | |
| Results article | ORACLE II results | 31/03/2001 | Yes | No | |
| Results article | ORACLE trials results | 01/06/2005 | Yes | No | |
| Results article | ORACLE I trial results | 11/10/2008 | Yes | No | |
| Results article | ORACLE II trial results | 11/10/2008 | Yes | No |
Editorial Notes
05/07/2018: Internal review
