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

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.

Study Overview

• Status: Completed
• Conditions: Pre-term Premature Rupture of Membranes
• Intervention / Treatment: Drug: Azithromycin; Drug: Erythromycin

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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Sāhīwāl, Punjab Province, Pakistan, 57000
      • Sahiwal Teaching Hospital , Sahiwal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Azithromycin Group; Participants will receive oral azithromycin as per protocol.	Drug: Azithromycin; Azithromycin 500 mg orally once daily for 7 consecutive days
Experimental: Erythromycin Group; Participants will receive oral erythromycin as per protocol.	Drug: Erythromycin; Erythromycin 250 mg orally every 6 hours for 7 consecutive days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: District Headquarters Teaching Hospital Sahiwal

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Erythromycin; Azithromycin
• Additional Relevant MeSH Terms: Organic Chemicals; Macrolides; Lactones; Polyketides; Azithromycin; Erythromycin
• Other Study ID Numbers: 130/IRV/SLMC/SWL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified individual participant data will not be shared due to institutional policies and concerns regarding participant confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No