Azithromycin for Preventing Maternal and Neonatal Infections During Labor.

NCT06958146 | Not Yet Recruiting Phase 4

• 1 other identifier: Azithromycin 2025
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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

Conditions

Maternal and Neonatal Sepsis; Intrapartum Antibiotics

Outcome Measures

Primary Outcomes (1)

• maternal infections

  birth to 6 weeks post partum

Secondary Outcomes (1)

• neonatal infections

  birth to 6 weeks post partum

Study Arms (2)

pregnanct ladies in labor receiving single dose azithromycin along with standard labor care

EXPERIMENTAL

The participants in this arm will receive a single dose of 2 g oral azithromycin along with standard care in the intrapartum period

Drug: oral azithromycin

Pregnant ladies in labor receiving only standard care and no oral azithromycin

PLACEBO COMPARATOR

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

Other: no azithromycin

Interventions

oral azithromycin DRUG

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

pregnanct ladies in labor receiving single dose azithromycin along with standard labor care

no azithromycin OTHER

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

Pregnant ladies in labor receiving only standard care and no oral azithromycin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Armed Forces Hospital, Pakistan: lead

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 6, 2025
• Study Start: May 1, 2025
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL