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Antibiotics to prevent preterm birth

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN84023116
Enrollment
2300
Registered
2007-12-18
Start date
2004-02-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm birth Pregnancy and Childbirth Preterm birth

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.

Sponsors

University of Liverpool (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
Preterm birth (less than 37 weeks gestation).

Secondary

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

Countries

Malawi

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026