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Not yet recruitingNCT06958146Updated May 6, 2025

Azithromycin for Preventing Maternal and Neonatal Infections During Labor.

A Phase 4 interventional study of oral azithromycin and no azithromycin in Maternal and Neonatal Sepsis and Intrapartum Antibiotics, sponsored by Armed Forces Hospital, Pakistan. Not yet recruiting. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-05-06.

Sponsored by Armed Forces Hospital, Pakistan · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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

02

Conditions studied

  • Maternal and Neonatal Sepsis
  • Intrapartum Antibiotics

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03

In context

Neonatal Sepsis

183 studies on the registry are indexed under Neonatal Sepsis; 41 are open to participants now.

This study's planned enrollment of 400 is above the median of 180 across 95 interventional studies indexed under Neonatal Sepsis.

Browse Neonatal Sepsis studies →

Lead sponsor

Armed Forces Hospital, Pakistan is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • pregnant with risk factors for sepsis like maternal fever , raised WBC count, chorioamnionitis, or having. history of any adverse even with macrolides
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
400 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Drugoral 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

  • Otherno azithromycin

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

06

What researchers measure

Primary outcomes

  1. maternal infections

    Time frame: birth to 6 weeks post partum

Secondary outcomes

  1. neonatal infections

    Time frame: birth to 6 weeks post partum

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — we will upload the data on the website on clinicaltrials.gov

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06958146
Lead sponsor
Armed Forces Hospital, Pakistan
Responsible party
arshad khushdil (professor, Armed Forces Hospital, Pakistan) — Principal investigator
First posted
May 6, 2025
Start date
May 1, 2025 (estimated)
Primary completion
Aug 31, 2025 (estimated)
Completion
Aug 31, 2025 (estimated)
Last update
May 6, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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