Antibiotics to prevent preterm birth

ISRCTN	ISRCTN84023116
DOI	https://doi.org/10.1186/ISRCTN84023116
Protocol serial number	065810/Z/01/Z
Sponsor	University of Liverpool (UK)
Funders	The Wellcome Trust (UK) (grant ref: 065810), Pfizer Inc. (USA) - supplied drug and placebo

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Jim Neilson
Scientific

School of Reproductive and Developmental Medicine
University of Liverpool
1st floor, Liverpool Women's Hospital
Liverpool
L8 7SS
United Kingdom

Phone	+44 (0)151 702 4100
Email	jneilson@liv.ac.uk

Primary study design	Interventional
Study design	Four centre placebo-controlled, randomised trial
Secondary study design	Randomised controlled trial
Scientific title	A randomised, community-based trial of Azithromycin for the Prevention of Pre-term Labour in Malawi
Study acronym	APPLe
Study objectives	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.
Ethics approval(s)	College Of Medicine Research Ethics Committee (COMREC), Blantyre (Malawi) approved in November 2003
Health condition(s) or problem(s) studied	Preterm birth
Intervention	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.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Azithromycin
Primary outcome measure(s)	Preterm birth (less than 37 weeks gestation).
Key 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
Completion date	31/07/2007

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	2300
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/02/2004
Date of final enrolment	31/07/2007

School of Reproductive and Developmental Medicine

Liverpool
L8 7SS
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2009		Yes	No