NCT07394725

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: District Headquarters Teaching Hospital Sahiwal · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Background: Preterm premature rupture of membranes (PPROM) is a significant contributor to preterm births and neonatal morbidity worldwide. While erythromycin has traditionally been used for this purpose, limitations related to tolerability and dosing frequency have prompted the evaluation of alternative agents such as azithromycin. Objective: To compare the clinical efficacy of azithromycin versus erythromycin in the management of PPROM, focusing on latency period, maternal infection rates, neonatal outcomes, and overall drug tolerability. Methodology: This randomized controlled trial was conducted at Sahiwal Teaching Hospital from 01-04-2024 to 31-03-2025. A total of 250 pregnant women with confirmed PPROM between 28+0 and 33+6 weeks of gestation were randomly allocated into two groups: Group A oral dose of azithromycin 500mg once daily for seven days, while Group B received erythromycin 250 mg orally every six hours for seven days. Primary outcomes included latency period, incidence of chorioamnionitis, mode of delivery, and key neonatal indicators such as APGAR scores, NICU admission rates, respiratory distress syndrome (RDS), and neonatal mortality.

Conditions

• Pre-term Premature Rupture of Membranes

Interventions

Type	Name	Description
DRUG	Erythromycin	Erythromycin 250 mg orally every 6 hours for 7 consecutive days.
DRUG	Azithromycin	Azithromycin 500 mg orally once daily for 7 consecutive days

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

1 site across 1 country: Pakistan