Azithromycin for Preventing Maternal and Neonatal Infections During Labor.

NCT ID: NCT06958146

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2025-08-31

Brief Summary

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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

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Conditions

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Maternal and Neonatal Sepsis Intrapartum Antibiotics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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

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

Group Type EXPERIMENTAL

oral azithromycin

Intervention Type 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

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

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

Group Type PLACEBO_COMPARATOR

no azithromycin

Intervention Type OTHER

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

Interventions

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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

Intervention Type DRUG

no azithromycin

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Armed Forces Hospital, Pakistan

OTHER

Sponsor Role lead

Responsible Party

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arshad khushdil

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Azithromycin 2025

Identifier Type: -

Identifier Source: org_study_id

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