Unlocking New Avenues: Azithromycin Vs Erythromycin in Pre-term, Pre-mature Rupture of Membrane Management

NCT07394725 | Completed Phase 1 DMC

• 1 other identifier: 130/IRV/SLMC/SWL
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial at Sahiwal Teaching Hospital (April 2024-March 2025) compared azithromycin and erythromycin for managing preterm premature rupture of membranes (PPROM) in 250 women (28-33+6 weeks gestation). Participants received either azithromycin 500 mg once daily or erythromycin 250 mg every six hours for seven days.

Conditions

Pre-term Premature Rupture of Membranes

Keywords

Azithromycin; Erythromycin

Outcome Measures

Primary Outcomes (2)

• Maternal Outcome

  Primary Outcome Measure 1 Name: Incidence of Clinical Chorioamnionitis Description: Clinical chorioamnionitis will be diagnosed based on predefined clinical criteria including maternal fever (≥38°C), maternal tachycardia, uterine tenderness, and foul-smelling amniotic fluid, supported by laboratory evidence of infection. Measurement Tool: Daily standardized clinical assessment and laboratory evaluation. Time Frame: Within 7 days of enrollment or until delivery, whichever occurs earlier. Unit of Measure: Number of participants diagnosed with clinical chorioamnionitis. Primary Outcome Measure 2 Name: Maternal Laboratory Evidence of Infection Description: Maternal inflammatory response will be assessed using total leukocyte count (TLC) and C-reactive protein (CRP) levels to support the diagnosis of infection. Measurement Tool: Venous blood sampling for TLC and CRP. Time Frame: Measured on alternate days until delivery

  07 Days

• Neonatal Outcomes

  Primary Outcome Measure 3 Name: Neonatal Birth Weight Description: Neonatal birth weight measured immediately after delivery. Measurement Tool: Calibrated digital weighing scale. Time Frame: At birth. Unit of Measure: Grams. Primary Outcome Measure 4 Name: APGAR Score at 1 Minute Description: Assessment of neonatal APGAR score at 1 minute after birth. Measurement Tool: Standard APGAR scoring system. Time Frame: 1 minute after birth. Unit of Measure: Score (0-10).

  07 days

Study Arms (2)

Azithromycin Group

EXPERIMENTAL

Participants will receive oral azithromycin as per protocol.

Drug: Azithromycin

Erythromycin Group

EXPERIMENTAL

Participants will receive oral erythromycin as per protocol.

Drug: Erythromycin

Interventions

Azithromycin DRUG

Azithromycin 500 mg orally once daily for 7 consecutive days

Azithromycin Group

Erythromycin DRUG

Erythromycin 250 mg orally every 6 hours for 7 consecutive days.

Erythromycin Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women
• Aged 18 to 40 years
• Singleton pregnancy with PPROM and
• weeks 0 days to 33 weeks 6 days of gestation.

You may not qualify if:

• Pregnancy was before 28 weeks
• Possible fetal defects
• Signs of active labor
• Major vaginal bleeding
• Signs of chorioamnionitis on arrival
• Placenta previa or placental abruption
• Allergic to macrolide antibiotics or received antibiotic treatment less than five days earlier were all excluded.

Sponsors & Collaborators

• District Headquarters Teaching Hospital Sahiwal: lead

Study Sites (1)

Sahiwal Teaching Hospital , Sahiwal

Sāhīwāl, Punjab Province, 57000, Pakistan

Location

MeSH Terms

Interventions

Erythromycin; Azithromycin

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: February 6, 2026
• Study Start: April 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)