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ISRCTN
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ISRCTN84023116
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DOI
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10.1186/ISRCTN84023116
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Antibiotics to prevent preterm birth
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Scientific title
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A randomised, community-based trial of Azithromycin for the Prevention of Pre-term Labour in Malawi
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Acronym
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APPLe
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Serial number at source
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065810/Z/01/Z
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Study hypothesis
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That routine antibiotic prophylaxis in a pregnant population with high burdens of infection, and high incidence of preterm birth, would reduce the incidence of prematurity.
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Lay summary
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Not provided at time of registration
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Ethics approval
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College Of Medicine Research Ethics Committee (COMREC), Blantyre (Malawi) approved in November 2003
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Study design
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Four centre placebo-controlled, randomised trial
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Countries of recruitment
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Malawi
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Disease/condition/study domain
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Preterm birth
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Participants - inclusion criteria
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1. Pregnant women less than 24 weeks gestational age by ultrasound at recruitment
2. No age restriction, apart from age being compatible with pregnancy
3. Intention to remain within the district throughout pregnancy
4. Informed consent
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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01/02/2004
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Anticipated end date
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31/07/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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2300
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Interventions
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Azithromycin 1 g orally or placebo at 16 - 24 weeks and 28 - 32 weeks. For main trial, follow-up was to 6 weeks after birth. Children have been followed up to 18 months of age.
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Primary outcome measure(s)
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Preterm birth (less than 37 weeks gestation).
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Secondary outcome measure(s)
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1. Mean gestational age at birth
2. Perinatal mortality
3. Birthweight
4. Malarial parasites at 28 - 32 weeks
5. Haemoglobin at 28 - 32 weeks
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Sources of funding
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1. The Wellcome Trust (UK) (grant ref: 065810)
2. Pfizer Inc. (USA) - supplied drug and placebo
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19956761
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Contact name
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Prof
Jim
Neilson
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Address
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School of Reproductive and Developmental Medicine
University of Liverpool
1st floor, Liverpool Women's Hospital
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City/town
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Liverpool
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Zip/Postcode
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L8 7SS
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Country
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United Kingdom
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Tel
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+44 (0)151 702 4100
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Fax
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+44 (0)151 702 4024
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Email
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jneilson@liv.ac.uk
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Sponsor
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University of Liverpool (UK)
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Address
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Brownlow Hill
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City/town
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Liverpool
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Zip/Postcode
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L69 3BX
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Country
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United Kingdom
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Email
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jdowson@liv.ac.uk
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Sponsor website:
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http://www.liv.ac.uk/
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Date applied
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14/12/2007
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Last edited
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21/03/2013
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Date ISRCTN assigned
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18/12/2007
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