Clinical trial NCT02528890: Group B Streptococcal Carrier State Prevalence Among Arab Pregnant Women in Northern Israel District
Official title: Group B Streptococcal Carrier State Prevalence Among Arab Pregnant Women in Northern Israel District
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Streptococcus B Carrier State Complicating Pregnancy
Keywords: group B streptococcus
GBS
Lead sponsor: The Nazareth Hospital, Israel
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 196
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
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.

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Age: 18 to 40
2. Origin: Arab
3. Gestational age: 34 to 40

Exclusion Criteria:

1. Rupture of membranes
2. Women in active labor who has had one or more vaginal examinations.

Primary outcomes:
measure: percentage of participants with positive GBS swab
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Nazareth
country: Israel
facility: Nazareth Hospital
Study officials:
affiliation: Nazareth Hospital EMMS
name: Marwan M Hakim, MD, DSc
role: PRINCIPAL_INVESTIGATOR
References: