Azithromycin for Preventing Maternal and Neonatal Infections During Labor.
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorArmed Forces Hospital, Pakistan
About this trial
In this study, we want to see the role of the antibiotic, azithromycin, in preventing maternal and neonatal infections, if the drug is given intrapartum to the mother
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
pregnant ladies with no risk factors for sepsis who go into spontaneous labor or induced labor
Disqualifiers
pregnant with risk factors for sepsis like maternal fever , raised WBC count, chorioamnionitis, or having. history of any adverse even with macrolides
Trial design
Design model
Parallel
Treatments tested in this trial
oral azithromycin
Drugwe will be administering single-dose oral azithromycin to ladies who go into labor and have no risk factors for sepsis, as there is increased risk of postpartum sepsis in both mother and neonate after normal vaginal delivery in low-income and middle-income countries
no azithromycin
Other interventionparticipants in this arm will be given only standard labor care and no oral azithromycin
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: pregnanct ladies in labor receiving single dose azithromycin along with standard labor careExperimental treatment 1 intervention
Group B: Pregnant ladies in labor receiving only standard care and no oral azithromycinPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
maternal infections
Time frame
birth to 6 weeks post partumSecondary outcomes
1
neonatal infections
Time frame
birth to 6 weeks post partumLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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