Overview of the Role of Antibiotics in Curtailing Labour and Early delivery
| ISRCTN | ISRCTN53994660 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53994660 |
| Protocol serial number | G9226450 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (UK) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Overview of the Role of Antibiotics in Curtailing Labour and Early delivery (ORACLE) |
| Study acronym | ORACLE |
| Study objectives | 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. |
| Health condition(s) or problem(s) studied | Obstetrics and gynaecology |
| Intervention | Broad spectrum antibiotics/placebo |
| Intervention type | Other |
| Primary outcome measure(s) |
Neonatal death, Chronic lung disease, Major cerebral pathology |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 10000 |
| Key inclusion criteria | Pregnant women less than 37 weeks gestation either in preterm labour or with premature rupture of membranes (PROM) |
| Key exclusion criteria | Need for immediate delivery, contraindications for antibiotics |
| Date of first enrolment | 01/07/1994 |
| Date of final enrolment | 31/03/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Obstetrics & Gynaecology
Leicester
LE2 7LX
United Kingdom
LE2 7LX
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 | 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
