The Relationship Between GBS Screening in Pregnant Women Insured in Maccabi Healthcare Services (MHS) and Early-onset Neonatal Disease in Israel

Streptococcal Infection Group B as Cause of Diseases Classified Elsewhere (Diagnosis) Clinical Trial

Official title:

The Relationship Between GBS Screening in Pregnant Women Insured in Maccabi Healthcare Services (MHS) and Early-onset Neonatal Disease in Israel

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04222907
• Other study ID #: 0008-17
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: September 20, 2019

Study information

• Verified date: April 2017
• Source: Assuta Hospital Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Determination of GBS colonization rates in Pregnant Women insured with Maccabi Health Services, Doctors' Compliance Rates for Referral for Testing, test execution rates, and Early-onset GBS Disease (EOGBSD) Rates in Israel. Determine the relationship between conducting a GBS test in pregnant women and EOGBSD in Israel.

Description:

There have been few studies in recent years, which has prompted us to undertake this study. Our aim was to examine the current colonization rates and attack rates in the Israeli population. Our secondary aim was to evaluate the need to readjust recommendations towards universal screening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54759
• Est. completion date: September 20, 2019
• Est. primary completion date: September 20, 2016
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All women with term pregnancies from 2015 to 2016 (until 20/9/16) insured by Maccabi Healthcare Services (MHS)

Exclusion Criteria:

• repeat pregnancies occurring in the same woman during the time period

• multiple pregnancies

• gestational age greater than 42 weeks due to probability of data inaccuracy

• women with missing information

Related Conditions & MeSH terms

• Infant, Newborn, Diseases
• Streptococcal Infection Group B as Cause of Diseases Classified Elsewhere (Diagnosis)
• Streptococcal Infections

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assuta Hospital Systems

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attack rate of early-onset GBS disease (EOGBSD)	Attack rate of (EOGBSD)	2015-2016