Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis & Death (PregnAnZI-2)
Neonatal SEPSIS
About this trial
This is an interventional prevention trial for Neonatal SEPSIS
Eligibility Criteria
Inclusion Criteria:
Pregnant women in labour (aged 16 years or more) attending the study health facilities for delivery who have previously given consent and willing to continue participation
Exclusion Criteria:
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 28 days Planned caesarean section or known required referral Known severe congenital malformation Intrauterine death confirmed before randomisation Known allergy to macrolides Already participating in another trial
Sites / Locations
- Clinical Research Unit of Nanoro
- Medical Research Council Unit The Gambia
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
AZITHROMYCIN
Placebo oral tablet
A single dose of 2G Azithromycin or Placebo will be administered orally to women in labour
A single dose of 2G Azithromycin or Placebo will be administered orally to women in labour