Group B Streptococcal Carrier State Prevalence Among Arab Pregnant Women in Northern Israel District
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- percentage of participants with positive GBS swab
研究概览
简要总结
The incidence of early neonatal GBS (group B Streptococcus) infection in the Nazareth Hospital through the years 2006-2013 has been higher compared to the national average. On reviewing all the cases of infants with early GBS infection, revealed that some of these infants were born to mothers who are not included in any of the high-risk groups that need to have prophylactic antibiotic treatment before delivery. Therefore, the question was whether pregnant Arab women in the North district of Israel have a higher GBS carrier state rate than the general rate in Israel?
详细描述
Signs of early onset GBS infection of the newborn appear during the first week of life. Usually, the bacteria pass from a GBS carrier mother to the newborn during labor. The infection can cause multi-system problems such as pneumonia, meningitis and even death of the newborn. The prevention of the disease is best achieved by prophylactic antibiotics administered to the mother during labor.
In order to prevent early onset GBS infection of the newborn, pregnant women are treated with preventive antibiotics during labor based on either of two protocols:
A. Risk factors: Women with risk factors such as premature birth, prolonged premature rupture of membranes, intra-partum maternal fever or a previous child with GBS infection are treated.
B. Universal screening: Towards the end of pregnancy, at 35 - 37th week, a vaginal/anal swab for GBS is taken, and those found positive will be treated.
According to the Israeli Ministry of Health regulations' from July 2005 it is not accepted to routinely perform screening for GBS in pregnant women at 35-37th week of pregnancy. Therefore, the Israeli approach to prevent early neonatal GBS infection is based mainly on antibiotic prophylaxis treatment during labor of all pregnant women with risk factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age: 18 to 40
- •Origin: Arab
- •Gestational age: 34 to 40
排除标准
- •Rupture of membranes
- •Women in active labor who has had one or more vaginal examinations.
结局指标
主要结局
percentage of participants with positive GBS swab
时间窗: one year
GBS swab results are: "+" = positive, which means the participant is a carrier for GBS or "-" = negative, which means the participant is not a carrier for GBS
次要结局
未报告次要终点
研究者
Marwan Hakim
Dr.
The Nazareth Hospital, Israel