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NCT Number: NCT07394725

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.

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Key information

Conditions

Pre-term Premature Rupture of Membranes

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Sahiwal Teaching Hospital , Sahiwal

Sāhīwāl, Punjab Province, 57000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Erythromycin

Drug

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

Azithromycin

Drug

Azithromycin 500 mg orally once daily for 7 consecutive days

Primary outcomes

  1. Maternal Outcome

    Time frame: 07 Days

    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

  2. Neonatal Outcomes

    Time frame: 07 days

    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).

Sponsors and collaborators

Lead sponsor

District Headquarters Teaching Hospital Sahiwal

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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