Condition category
Pregnancy and Childbirth
Date applied
14/12/2007
Date assigned
18/12/2007
Last edited
21/03/2013
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

Prof Jim Neilson

ORCID ID

Contact details

School of Reproductive and Developmental Medicine
University of Liverpool
1st floor
Liverpool Women's Hospital
Liverpool
L8 7SS
United Kingdom
+44 (0)151 702 4100
jneilson@liv.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

065810/Z/01/Z

Study information

Scientific title

A randomised, community-based trial of Azithromycin for the Prevention of Pre-term Labour in Malawi

Acronym

APPLe

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.

Ethics approval

College Of Medicine Research Ethics Committee (COMREC), Blantyre (Malawi) approved in November 2003

Study design

Four centre placebo-controlled, randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Azithromycin

Primary outcome measures

Preterm birth (less than 37 weeks gestation).

Secondary outcome measures

1. Mean gestational age at birth
2. Perinatal mortality
3. Birthweight
4. Malarial parasites at 28 - 32 weeks
5. Haemoglobin at 28 - 32 weeks

Overall trial start date

01/02/2004

Overall trial end date

31/07/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

2300

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/02/2004

Recruitment end date

31/07/2007

Locations

Countries of recruitment

Malawi

Trial participating centre

School of Reproductive and Developmental Medicine
Liverpool
L8 7SS
United Kingdom

Sponsor information

Organisation

University of Liverpool (UK)

Sponsor details

Brownlow Hill
Liverpool
L69 3BX
United Kingdom
jdowson@liv.ac.uk

Sponsor type

University/education

Website

http://www.liv.ac.uk/

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 065810)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Pfizer Inc. (USA) - supplied drug and placebo

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19956761

Publication citations

  1. Results

    van den Broek NR, White SA, Goodall M, Ntonya C, Kayira E, Kafulafula G, Neilson JP, The APPLe study: a randomized, community-based, placebo-controlled trial of azithromycin for the prevention of preterm birth, with meta-analysis., PLoS Med., 2009, 6, 12, e1000191, doi: 10.1371/journal.pmed.1000191.

Additional files

Editorial Notes