Status:
COMPLETED
Prevention of Bacterial Infections in Newborn
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Conditions:
Neonatal Infection
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief Summary
The last decade has witnessed an important reduction of the mortality in children under 5 years but such reduction has not impacted in neonates. Mortality in neonates contributes 40% of all deaths occ...
Eligibility Criteria
Inclusion
- Pregnant women (aged 18 to 45 years)
- in labour
- attending a health centre in western Gambia for delivery
Exclusion
- Known HIV infection.
- Any chronic or acute conditions of the women that might interfere with the study as judged by the research clinician.
- Planned travelling out of the catchment area during the following 2 months (follow-up period)
- Planned caesarean section
- Known required referral
- Known multiple pregnancy
- Known severe congenital malformation
- Intrauterine death confirmed before randomization
- Known allergy to macrolides
- Consumption of antibiotic within the week before randomisation
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
829 Patients enrolled
Trial Details
Trial ID
NCT01800942
Start Date
February 1 2013
End Date
August 1 2015
Last Update
March 22 2018
Active Locations (1)
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1
Medical Research Council Unit
Fajara, The Gambia