Group B Streptococcal Carrier State Prevalence Among Arab Pregnant Women in Northern Israel District (GBS)

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?

Study Overview

• Status: Completed
• Conditions: Streptococcus B Carrier State Complicating Pregnancy
• Intervention / Treatment: Other: vaginal/anal swab for GBS from all participants

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.

• Study Type: Observational
• Enrollment (Actual): 196

Contacts and Locations

Study Locations

• Israel
  • Nazareth, Israel, 16100
    • Nazareth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
preganat women between 34 - 40 weeks; Eligible pregnant women, who meet the inclusion criteria, will have a vaginal/anal swab taken to identify positive GBS carriers by PCR (polymerase chain reaction) test.	Other: vaginal/anal swab for GBS from all participants; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of participants with positive GBS swab	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	one year

Collaborators and Investigators

• Sponsor: The Nazareth Hospital, Israel
• Investigators: Principal Investigator: Marwan M Hakim, MD, DSc, Nazareth Hospital EMMS

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: August 7, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimate): August 19, 2015

Study Record Updates

• Last Update Posted (Estimate): April 5, 2016
• Last Update Submitted That Met QC Criteria: April 4, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: group B streptococcus; GBS
• Additional Relevant MeSH Terms: Pregnancy Complications
• Other Study ID Numbers: 15-2015