Unlocking New Avenues: Azithromycin Vs Erythromycin in Pre-term, Pre-mature Rupture of Membrane Management
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Maternal Outcome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women
- •Aged 18 to 40 years
- •Singleton pregnancy with PPROM and
- •28 weeks 0 days to 33 weeks 6 days of gestation.
排除标准
- •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.
研究组 & 干预措施
Azithromycin Group
Participants will receive oral azithromycin as per protocol.
干预措施: Azithromycin (Drug)
Erythromycin Group
Participants will receive oral erythromycin as per protocol.
干预措施: Erythromycin (Drug)
结局指标
主要结局
Maternal Outcome
时间窗: 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
Neonatal Outcomes
时间窗: 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).
次要结局
未报告次要终点
研究者
Mahpara Shaukat
Associate Professor
District Headquarters Teaching Hospital Sahiwal