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

NCT02528890 | Completed DMC

• 1 other identifier: 15-2015
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

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?

Conditions

Streptococcus B Carrier State Complicating Pregnancy

Keywords

group B streptococcus; GBS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

vaginal/anal swab for GBS from all participants OTHER

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.

preganat women between 34 - 40 weeks

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Age: 18 to 40
• Origin: Arab
• Gestational age: 34 to 40

You may not qualify if:

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

Sponsors & Collaborators

• The Nazareth Hospital, Israel: lead

Study Sites (1)

Nazareth Hospital

Nazareth, 16100, Israel

Location

Study Officials

• Marwan M Hakim, MD, DSc

  Nazareth Hospital EMMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 19, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 5, 2016

Record last verified: 2016-04

Locations

IL (1)