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

NCT04222907 | Completed

• 1 other identifier: 0008-17
• Study Type: observational
• Target: 54,759
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Attack rate of early-onset GBS disease (EOGBSD)

  Attack rate of (EOGBSD)

  2015-2016

Study Arms (2)

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

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assuta Hospital Systems: lead

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 20 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 10, 2020
• Study Start: January 1, 2015
• Primary Completion: September 20, 2016
• Study Completion: September 20, 2019
• Last Updated: January 13, 2020

Record last verified: 2017-04