Condition category
Pregnancy and Childbirth
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
21/10/2008
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 DJ Taylor

ORCID ID

Contact details

Department of Obstetrics & Gynaecology
Clinical Sciences Building
Leicester Royal Infirmary
Leicester
LE2 7LX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9226450

Study information

Scientific title

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

Added 18/07/2007: Approved by West Midlands Multicentre Research Ethics Committee.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Obstetrics and gynaecology

Intervention

Broad spectrum antibiotics/placebo

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Neonatal death, Chronic lung disease, Major cerebral pathology

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/1994

Overall trial end date

31/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Pregnant women less than 37 weeks gestation either in preterm labour or with premature rupture of membranes (PROM)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

10000

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

United Kingdom

Trial participating centre

Department of Obstetrics & Gynaecology
Leicester
LE2 7LX
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

1. 2001 ORACLE I results in http://www.ncbi.nlm.nih.gov/pubmed/11293640
2. 2001 ORACLE II results in http://www.ncbi.nlm.nih.gov/pubmed/11293641
3. 2005 ORACLE trials results in http://www.ncbi.nlm.nih.gov/pubmed/15924546
4. 2008 ORACLE I trial results in http://www.ncbi.nlm.nih.gov/pubmed/18804274
5. 2008 ORACLE II trial results in http://www.ncbi.nlm.nih.gov/pubmed/18804276

Publication citations

  1. ORACLE II results

    Kenyon SL, Taylor DJ, Tarnow-Mordi W, , Broad-spectrum antibiotics for spontaneous preterm labour: the ORACLE II randomised trial. ORACLE Collaborative Group., Lancet, 2001, 357, 9261, 989-994.

  2. ORACLE trials results

    Gilbert RE, Pike K, Kenyon SL, Tarnow-Mordi W, Taylor DJ, The effect of prepartum antibiotics on the type of neonatal bacteraemia: insights from the MRC ORACLE trials., BJOG, 2005, 112, 6, 830-832, doi: 10.1111/j.1471-0528.2005.00558.x.

  3. ORACLE II trial results

    Kenyon S, Pike K, Jones DR, Brocklehurst P, Marlow N, Salt A, Taylor DJ, Childhood outcomes after prescription of antibiotics to pregnant women with spontaneous preterm labour: 7-year follow-up of the ORACLE II trial., Lancet, 2008, 372, 9646, 1319-1327, doi: 10.1016/S0140-6736(08)61203-9.

  4. Kenyon SL, Taylor DJ, Tarnow-Mordi W, , Broad-spectrum antibiotics for preterm, prelabour rupture of fetal membranes: the ORACLE I randomised trial. ORACLE Collaborative Group., Lancet, 2001, 357, 9261, 979-988.

  5. Kenyon S, Pike K, Jones DR, Brocklehurst P, Marlow N, Salt A, Taylor DJ, Childhood outcomes after prescription of antibiotics to pregnant women with preterm rupture of the membranes: 7-year follow-up of the ORACLE I trial., Lancet, 2008, 372, 9646, 1310-1318, doi: 10.1016/S0140-6736(08)61202-7.

Additional files

Editorial Notes