Duration of Antibiotics Treatment With Cefazolin and Clarithromycin in Women With Preterm Premature Rupture of Membrane, Phase III Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Neonatal composite morbidity
研究概览
简要总结
The purpose of this study is to compare the neonatal outcome and infant neurologic outcome whose mother were treated with cefazolin plus clarithromycin for one week or until delivery after preterm premature rupture of membrane.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •preterm premature rupture of membrane(PPROM), PA 22+0~34+0wks
- •ROM <72 hrs before randomization
- •cervical dilatation <3cm
- •uterine contraction less than 4 times per 1 hr
排除标准
- •Major fetal malformation
- •Rupture of the membrane >72hrs before randomization
- •Vaginal bleeding
- •IIOC (incompetent internal os of cervix)
- •Placenta previa
- •Gestational diabetes or overt diabetes
- •Hypertensive disorders in pregnancy
- •Liver cirrhosis
- •Acute renal failure
研究组 & 干预措施
one-week treatment group
Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization for one week
干预措施: Cefazolin (Drug)
one-week treatment group
Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization for one week
干预措施: Clarithromycin (Drug)
until-delivery treatment group
Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization until delivery
干预措施: Cefazolin (Drug)
until-delivery treatment group
Cefazolin 1.0gm IVs q 12 hours plus clarithromycin 500mg po bid after randomization until delivery
干预措施: Clarithromycin (Drug)
结局指标
主要结局
Neonatal composite morbidity
时间窗: Participants will be followed for duration of hospital day after delivery, an expected average of 8 weeks
1. respiratory distress syndrome(RDS) 2. bronchopulmonary dysplasia(BPD) 3. intraventricular hemorrhage(IVH,≥grade 3) 4. retinopathy of prematurity(ROP,≥grade 3) 5. necrotizing enterocolitis(NEC,≥stage 2) 6. proven neonatal sepsis
次要结局
- infantile neurologic outcome(at 6 months and 1 year of corrected age)
研究者
Oh Soo Young
Associate professor
Samsung Medical Center