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Azithromycin for Preventing Maternal and Neonatal Infections During Labor.

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06958146
Enrollment
400
Registered
2025-05-06
Start date
2025-05-01
Completion date
2025-08-31
Last updated
2025-05-06

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

Conditions

Intrapartum Antibiotics, Maternal and Neonatal Sepsis

Brief summary

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

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

OTHERno azithromycin

participants in this arm will be given only standard labor care and no oral azithromycin

Sponsors

Armed Forces Hospital, Pakistan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
maternal infectionsbirth to 6 weeks post partum

Secondary

MeasureTime frame
neonatal infectionsbirth to 6 weeks post partum

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026