Azithromycin for Preventing Maternal and Neonatal Infections During Labor.

April 28, 2025 updated by: arshad khushdil, Armed Forces Hospital, Pakistan

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: 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
Placebo Comparator: 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
Other: no azithromycin
participants in this arm will be given only standard labor care and no oral azithromycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
maternal infections
Time Frame: birth to 6 weeks post partum
birth to 6 weeks post partum

Secondary Outcome Measures

Outcome Measure
Time Frame
neonatal infections
Time Frame: birth to 6 weeks post partum
birth to 6 weeks post partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Armed Forces Hospital, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

April 28, 2025

First Submitted That Met QC Criteria

April 28, 2025

First Posted (Actual)

May 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Azithromycin 2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

we will upload the data on the website on clinicaltrials.gov

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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