Comparison of efficacy of two prophylactic antibiotic regimens for PPROM-A randomised controlled trial
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Latency period
研究概览
简要总结
Assessed for Eligibility (n) ,excluded(x)-Chorioamnionitis ï‚· Fetal distress ï‚· Placental abruption ï‚· Active labour ï‚· Not giving consent
All cases of PPROM meeting inclusion criteria Randomized (n-x=232)
Group A = 116 AMPICILLIN AND AZITHROMYCIN : INJ.AMPICILLIN 2GM QID I.V FOR 48 HOURS+ TAB. AZITHROMYCIN 1GM STAT. FOLLOWED BY TAB AMOXICILLIN 250 MG TDS + TAB ERYTHROMYCIN 250MG TDS FOR 5 DAYS.
Group B=116 CEFUROXIME AND AZITHROMYCIN : INJ.CEFUROXIME 750 MG TDS FOR 48 HOURS + TAB AZITHROMYCIN 1GM PO STAT. FOLLOWED BY TAB AMOXICILLIN 250 MG TDS + TAB ERYTHROMYCIN 250MG TDS FOR 5 DAYS.
Fetal Monitoring  DFMC, NST, Biophysical profile twice a week  Maternal Monitoring  For signs of infection – PR, Temp, uterine discharge, TLC, CRP  Screening for infection  Urine & Vaginal culture
ï‚· Comparison of: ï‚· Latency period ï‚· Adverse neonatal outcome ï‚· Maternal infectious morbidity
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •â€“ Patient giving written informed consent – Singleton pregnancy, PPROM after 24 weeks of gestation & before 37 weeks.
排除标准
- •Not giving consent – Conditions requiring expedite delivery or contraindication of conservative management like: Chorioamnionitis Fetal distress Placental abruption Active labour.
结局指标
主要结局
Latency period
时间窗: Latency period-date of randomisation until date of delivery | Early neonatal sepsis rate- within 3 days of delivery | Chorioamnionitis rate-from day of randomisation until date of clinical/laboratory Chorioamnionitis diagnosis assessed up to 10 weeks
Early neonatal sepsis rate-positive blood culture
时间窗: Latency period-date of randomisation until date of delivery | Early neonatal sepsis rate- within 3 days of delivery | Chorioamnionitis rate-from day of randomisation until date of clinical/laboratory Chorioamnionitis diagnosis assessed up to 10 weeks
Chorioamnionitis rate
时间窗: Latency period-date of randomisation until date of delivery | Early neonatal sepsis rate- within 3 days of delivery | Chorioamnionitis rate-from day of randomisation until date of clinical/laboratory Chorioamnionitis diagnosis assessed up to 10 weeks
次要结局
- Neonatal weight(Apgar score)
研究者
Dr Jyoti
KING GEORGES MEDICAL UNIVERSITY, LUCKNOW