Streptococcal Infection Group B as Cause of Diseases Classified Elsewhere (Diagnosis)NCT04222907
The Relationship Between GBS Screening in Pregnant Women Insured in Maccabi Healthcare Services (MHS) and Early-onset Neonatal Disease in Israel
An observational study of Streptococcal Infection Group B as Cause of Diseases Classified Elsewhere (Diagnosis), run by Assuta Hospital Systems.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Streptococcal Infection Group B as Cause of Diseases Classified Elsewhere (Diagnosis)
- How many people
- 54,759 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 20 Sep 2019
- How long will I take part?
- 20 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
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.
Who may be able to join
- All women with term pregnancies from 2015 to 2016 (until 20/9/16) insured by Maccabi Healthcare Services (MHS)
Who cannot join
- 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
About this study
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.
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Attack rate of early-onset GBS disease (EOGBSD)
Attack rate of (EOGBSD)
Measured: 2015-2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start1 Jan 2015
- Primary completion20 Sep 2016
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcal Infection Group B as Cause of Diseases Classified Elsewhere (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 54,759 participants (actual)
- Target duration
- 20 Months
Sponsor and investigators
- Lead sponsor
- Assuta Hospital Systems
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222907
- Sponsor's protocol ID
- 0008-17
- Status last verified
- Apr 2017
- First submitted
- 7 Jan 2020
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between GBS Screening in Pregnant Women Insured in Maccabi Healthcare Services (MHS) and Early-onset Neonatal Disease in Israel
- ClinicalTrials.gov ID
- NCT04222907
- Acronym / sponsor ID
- 0008-17
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54,759 participants (actual)
- Lead sponsor
- Assuta Hospital SystemsUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 20 Sep 2016 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 20 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All women with term pregnancies from 2015 to 2016 (until 20/9/16) insured by Maccabi Healthcare Services (MHS)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Attack rate of early-onset GBS disease (EOGBSD)
Time frame: 2015-2016
Attack rate of (EOGBSD)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcal Infection Group B as Cause of Diseases Classified Elsewhere (Diagnosis), run by Assuta Hospital Systems.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attack rate of early-onset GBS disease (EOGBSD) (time frame: 2015-2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.