Azithromycin for Preventing Maternal and Neonatal Infections During Labor.

Phase 4

Not yet recruiting

• Conditions: Maternal and Neonatal Sepsis; Intrapartum Antibiotics
• Interventions: Drug: oral azithromycin; Other: no azithromycin

• Registration Number: NCT06958146
• Lead Sponsor: Armed Forces Hospital, Pakistan

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-28
• Study First Submitted QC: 2025-04-28
• Last Update Submitted: 2025-04-28
• Study Start: 2025-05-01
• Study First Posted: 2025-05-06
• Last Update Posted: 2025-05-06
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pregnanct ladies in labor receiving single dose azithromycin along with standard labor care	oral azithromycin	The participants in this arm will receive a single dose of 2 g oral azithromycin along with standard care in the intrapartum period
Pregnant ladies in labor receiving only standard care and no oral azithromycin	no azithromycin	participants in this arm will be given only standard labor care and no antibiotics

Primary Outcome Measures

Name	Time	Method
maternal infections	birth to 6 weeks post partum

Secondary Outcome Measures

Name	Time	Method
neonatal infections	birth to 6 weeks post partum