and Infectious Morbidity Among Women With Meconium-stained Amniotic Fluid at Term, Between Those Who Will be Treated With Prophylactic Antibiotics Zinacef vs. Placebo
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- peripartum infections
研究概览
简要总结
Our randomized controlled double blind clinical trail aims to compare maternal and neonatal infectious morbidity between women with meconium-stained amniotic fluid treated with zinacef vs. placebo.
详细描述
The relationship between meconium staining and chorioamnionitis, as well as neonatal sepsis, has been documented, yet the precise mechanisms remain unclear. Additionally, the correlation between prolonged labor and meconium staining was described in the past. In light of these findings, our randomized controlled double blind trail aims to compare maternal and neonatal infectious morbidity between women with meconium-stained amniotic fluid treated with zinacef vs. placebo. Additionally, we aimed to assess the distribution of pathogens in chorioamnionitic swab cultures relative to the antibiotic treatment
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 (Participant)
盲法说明
Single masking - Participant
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •singleton pregnancy at term
- •meconium-stained amniotic fluid
排除标准
- •Intrauterine fetal death
- •GBS carriers
- •zinacef allergy
- •antibiotic treatment for other indication
研究组 & 干预措施
Zinacef treatment
women with meconium-stained amniotic fluid treated with zinacef 750 mg X3/d
干预措施: zinacef tretment (Drug)
control
women with meconium-stained amniotic fluid treated with I.V SALINE 100 CCX3/d
干预措施: Placebo (Other)
结局指标
主要结局
peripartum infections
时间窗: 7 days
chorioamnionitis and endometritis
次要结局
- intrapartum fever(during labor up to 2 hours postpartum)
- neonatal antibiotic treatment(7 days)
- NICU admission(1 week)
研究者
Dr. Maya Wolf
Head of Maternal and Fetal medicine unit
Western Galilee Hospital-Nahariya