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Antibiotics to prevent preterm birth
ISRCTN ISRCTN84023116
DOI 10.1186/ISRCTN84023116
ClinicalTrials.gov identifier
EudraCT number
Public title Antibiotics to prevent preterm birth
Scientific title A randomised, community-based trial of Azithromycin for the Prevention of Pre-term Labour in Malawi
Acronym APPLe
Serial number at source 065810/Z/01/Z
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval College Of Medicine Research Ethics Committee (COMREC), Blantyre (Malawi) approved in November 2003
Study design Four centre placebo-controlled, randomised trial
Countries of recruitment Malawi
Disease/condition/study domain Preterm birth
Participants - inclusion criteria 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
Participants - exclusion criteria Does not meet inclusion criteria
Anticipated start date 01/02/2004
Anticipated end date 31/07/2007
Status of trial Completed
Patient information material
Target number of participants 2300
Interventions 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.
Primary outcome measure(s) Preterm birth (less than 37 weeks gestation).
Secondary outcome measure(s) 1. Mean gestational age at birth
2. Perinatal mortality
3. Birthweight
4. Malarial parasites at 28 - 32 weeks
5. Haemoglobin at 28 - 32 weeks
Sources of funding 1. The Wellcome Trust (UK) (grant ref: 065810)
2. Pfizer Inc. (USA) - supplied drug and placebo
Trial website
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19956761
Contact name Prof  Jim  Neilson
  Address School of Reproductive and Developmental Medicine
University of Liverpool
1st floor, Liverpool Women's Hospital
  City/town Liverpool
  Zip/Postcode L8 7SS
  Country United Kingdom
  Tel +44 (0)151 702 4100
  Fax +44 (0)151 702 4024
  Email jneilson@liv.ac.uk
Sponsor University of Liverpool (UK)
  Address Brownlow Hill
  City/town Liverpool
  Zip/Postcode L69 3BX
  Country United Kingdom
  Email jdowson@liv.ac.uk
  Sponsor website: http://www.liv.ac.uk/
Date applied 14/12/2007
Last edited 21/03/2013
Date ISRCTN assigned 18/12/2007
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