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

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.

Study Overview

• Status: Completed
• Conditions: Streptococcal Infection Group B as Cause of Diseases Classified Elsewhere (Diagnosis)

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 54759

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Full-term pregnancies were defined as gestational age 37 weeks and above. Pregnancies were identified by a pregnancy code accessed by the primary physician indicating that the patient is pregnant, open pregnancy record in the medical record or child linked to the mother's id. Gestational age was defined by last menstrual period (LMP) or first obstetric ultrasound if LMP was unknown.We identified and excluded 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 and women with missing information.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Women screened for GBS; All women who were pregnant during 2015-2016 and delivery was between 37-42 weeks who were screened for GBS during pregnancy
Women not screened for GBS; All women who were pregnant during 2015-2016 and delivery was between 37-42 weeks who were not screened for GBS during pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attack rate of early-onset GBS disease (EOGBSD)	Attack rate of (EOGBSD)	2015-2016

Collaborators and Investigators

• Sponsor: Assuta Hospital Systems

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): September 20, 2016
• Study Completion (Actual): September 20, 2019

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infant, Newborn, Diseases; Streptococcal Infections
• Other Study ID Numbers: 0008-17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No