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

Streptococcus B Carrier State Complicating Pregnancy Clinical Trial

— GBS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528890
• Other study ID #: 15-2015
• Status: Completed
• Phase: N/A
• First received: August 7, 2015
• Last updated: April 4, 2016
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: The Nazareth Hospital, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy Complications
• Streptococcus B Carrier State Complicating Pregnancy

Intervention

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.

Locations

Country	Name	City	State
Israel	Nazareth Hospital	Nazareth

Sponsors (1)

Lead Sponsor	Collaborator
The Nazareth Hospital, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No