Azithromycin for Preventing Maternal and Neonatal Infections During Labor.

Armed Forces Hospital, Pakistan

Status and phase: Not yet enrolling; Phase 4

Conditions: Intrapartum Antibiotics; Maternal and Neonatal Sepsis

Treatments: Drug: oral azithromycin; Other: no azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT06958146

Azithromycin 2025

Details and patient eligibility

About

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

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

Drug: oral azithromycin

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

Placebo Comparator group

Description:

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

Treatment:

Other: no azithromycin