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CompletedNCT04222907Updated Jan 13, 2020

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

An observational study in Streptococcal Infection Group B as Cause of Diseases Classified Elsewhere (Diagnosis), sponsored by Assuta Hospital Systems. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2020-01-13.

Primary conditionnone(registry's first term: Disease)No conditionIs this wrong?Disease describes something many studies share rather than a condition a study is about. The study names no condition we can place it under, so it is not compared with other studies by condition.

Sponsored by Assuta Hospital Systems · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
54,759
Sex
Female
01

Study 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.

Read the 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.

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Conditions studied

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

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03

In context

Lead sponsor

Assuta Hospital Systems is the lead sponsor of 34 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
54,759 participants (actual)
Target follow-up
20 Months
Patient registry
Yes

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. Attack rate of early-onset GBS disease (EOGBSD)

    Attack rate of (EOGBSD)

    Time frame: 2015-2016

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Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2015 to primary completion in Sep 2016, 20 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 7, 2020
First posted
Jan 10, 2020
StartActual
Jan 1, 2015
Primary completionActual
Sep 20, 2016
CompletionActual
Sep 20, 2019
Last update
Jan 13, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04222907
Lead sponsor
Assuta Hospital Systems
Responsible party
Sponsor
First posted
Jan 10, 2020
Start date
Jan 1, 2015
Primary completion
Sep 20, 2016
Completion
Sep 20, 2019
Last update
Jan 13, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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