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Not yet recruiting NCT06958146

Azithromycin for Preventing Maternal and Neonatal Infections During Labor.

Phase IV Interventional Maternal and Neonatal Sepsis Intrapartum Antibiotics

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: oral azithromycin, no azithromycin.
Who it may be relevant to
Registry conditions: Maternal and Neonatal Sepsis, Intrapartum Antibiotics. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impact of Single Dose Azithromycin During Labor on Maternal and Neonatal Infections

Overview

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

Interventions

  • Drug oral azithromycin
    we 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
  • Other no azithromycin
    participants in this arm will be given only standard labor care and no oral azithromycin

Primary outcome measures

  • maternal infections [Time frame: birth to 6 weeks post partum]
Secondary outcome measures (1)
  • neonatal infections [Time frame: birth to 6 weeks post partum]

Eligibility criteria

Inclusion criteria

  • pregnant ladies with no risk factors for sepsis who go into spontaneous labor or induced labor

Exclusion criteria

  • pregnant with risk factors for sepsis like maternal fever , raised WBC count, chorioamnionitis, or having. history of any adverse even with macrolides

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06958146 · Azithromycin 2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗