Group B Streptococcal Carrier State Prevalence Among Arab Pregnant Women in Northern Israel District
Condition: Streptococcus B Carrier State Complicating Pregnancy
MeSH terms: Pregnancy Complications
Study type: Observational

Summary: 
      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?
    

Detailed description: 
      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.

      In a study conducted at the Western Galilee Medical Center in the city of Nahariya and
      published in 2006, there was a significant increase in the GBS carrier state rate compared to
      previously published studies. It was also found that higher GBS carrier state rates prevail
      among Arab women compared to Jewish women.

      The primary question of this study is to calculate GBS carrier state prevalence among
      pregnant Arab women attending the labor ward at the Nazareth Hospital at the 34 to 40th week
      of their pregnancy.

      A vaginal / anal swab will be taken from all eligible participants to identify GBS carriers
      by PCR (polymerase chain reaction) test.
    

Intervention name(s): vaginal/anal swab for GBS from all participants
Intervention type(s): Other
Intervention description(s): All eligible pregnant women, who meet the inclusion criteria and gave their informed consent to participate in the study has to complete a questionnaire and have a vaginal / anal swab taken to identify positive GBS carriers by PCR (polymerase chain reaction) test.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study will include 184 participants who meet the inclusion criteria and gave their
        informed consent to participate. The sample size enables a confidence level of 95% within a
        5% range of the GBS carrier rate, assuming that the rate is close to 17%. The investigators
        assume to identify 23 to 41 carriers, which will allow comparison of demographic variables
        between carriers and non-carriers.
      
Keywords: group B streptococcus; GBS