a prospective study to compare the efficacy of combination of ampicillin and azithromycin with ampicillin and erythromycin for prolonging latency in preterm premature rupture of membranes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Latency
研究概览
简要总结
This study was a randomized prospective controlled study comparing the efficacy of combination of two drugs ampicillin plus azithromycin(group-A) with ampicillin plus erythromycin(Group-B) in pregnant patients with preterm premature rupture of membranes. The study was conducted at R.G.KAR Medical college, Kolkata with a samle size 114 and study duration of one year. The primary outcome of the study was latency and the secondary outcomes were safety of antibiotics,gestational age at delivery,chorioamnionitis,puerperal sepsis,birth weight,APGAR score,RDS(respiratory distress syndrome),neonatal sepsis, neonatal mortality,days of NICU stay. After statistical analysis, no statistical difference was found between two groups in term of latency,maternal and neonatal outcomes except statistically significant difference in mean birth weight and NICU stay between two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women of 19 years to 40 years of age with preterm premature rupture of membranes and not in labour.
- •Gestational age of 28 to 34 weeks.
- •Single foetus gestation Randomization within 36 hours of rupture of membranes.
- •Cervical dilatation less than or equal 04 cm.
排除标准
- •Gestational age <24 weeks and >34 weeks In preterm labour Cervical cerclage in situ Multifetal gestation Vaginal bleeding/Foul smelling vaginal discharge Maternal or foetal indication for delivery Placental abnormality H/o amniocentesis Had received corticosteroid or antibiotic within the last seven days Carrying a foetus with lethal anomalies H/o foetal surgery H/o abdominal trauma On antiretroviral therapy Known allergy or cntraindication to use of ampicillin, azithromycin and erythromycin.
结局指标
主要结局
Latency
时间窗: Latency - from first antibiotic dose administration to the time of delivery
次要结局
- Safety of antibiotics(Gestational age at delivery)