GBSNCT04116645
Time Frame for GBS Screening
An observational study of GBS and Group B Streptococcal Infection, run by Rambam Health Care Campus.
Trial summary
All pregnant women prenatally being followed up or admitted at Rambam HealthCare Campus, Haifa, Israel are potential participants in the study. If a patient is agreeable, the nurse/physician/research coordinator will obtain informed consent. Once informed consent is obtained, the patient can be swabbed for GBS. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- GBS, Group B Streptococcal Infection
- What is being tested?
- genital and rectal swab
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 30 Oct 2024
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: We plan to conduct an open label prospective trial of all women with a singleton pregnancy which will be screened for GBS in four different time-points during their pregnancy, from 30 weeks' gestation up to delivery - 30, 32, 35 weeks' gestational age and at delivery.
Who may be able to join
- Pregnant women that are being followed up prenatally or admitted at Rambam HealthCare Campus, Haifa, Israel and are planning to deliver there.
- Women at gestational age 300/7 or less.
Who cannot join
- Age 18 and under.
- Women with previous delivery of an infant affected by GBS disease.
- Women with known bacteriuria in the current pregnancy.
- Women whom are planning not to deliver at Rambam HealthCare Campus.
- Women who will not consent to participate in the study.
About this study
All pregnant women prenatally being followed up or admitted at Rambam HealthCare Campus, Haifa, Israel are potential participants in the study. If a patient is agreeable, the nurse/physician/research coordinator will obtain informed consent.
Once informed consent is obtained, the patient can be swabbed for GBS. The swabs will be obtained at the routine follow-up at the clinic at 30, 32 and 35 weeks' gestation.
Read more
If a patient is found to have a positive GBS culture at 35 weeks, she will receive antibiotic treatment during labour according to the protocol.
GBS swabs taken at delivery will be compared to previous swabs taken at an earlier gestational age in order to evaluate sensitivity, specificity, positive and negative predictive values of GBS swabs at each week of gestation and to determine the value of our primary hypothesis.
Read the detailed description
- All pregnant women prenatally being followed up or admitted at Rambam HealthCare Campus, Haifa, Israel are potential participants in the study.
- Most high-risk pregnant women have their routine follow ups every two weeks or less from the beginning of the third trimester (between 28 and 32 weeks' gestation).
- The nurse/physician/research coordinator in the clinic will discuss the trial with those women. If a patient is agreeable, the nurse/physician/research coordinator will obtain informed consent.
- Once informed consent is obtained, the patient can be swabbed for GBS.
- The swabs will be obtained at the routine follow-up at the clinic at 30, 32 and 35 weeks' gestation. Then, they will be handed to the nurse/physician/research coordinator and transferred to the lab for analysis.
- Swabs for GBS culture should be obtained, ideally before digital examination or use of lubricants, from both the lower vagina (vaginal introitus) and rectum (insert swab through the anal sphincter) to achieve maximum sensitivity. Either two swabs (one for each site) or a single swab can be used; one swab is more cost saving. The swabs will be obtained by the patient herself after appropriate instruction as studies have shown equivalent sensitivity between the healthcare provider and the patient herself20.
- The swabs should be placed promptly into non-nutrient transport media (eg, Amies or Stuart's without charcoal) and transported at room temperature (in temperate climates) or refrigerated. The swabs are then transferred to a selective enrichment broth at a laboratory experienced in the isolation of GBS, incubated overnight at 37ºC, and subcultured onto blood agar plates. Cultures require 24 to 48 hours to show positive results. It takes 48 hours to definitively exclude GBS20.
- The swabs will be kept for seven days, then will be removed by environmental services for their discard process.
- A log of all patients who meet all inclusion criteria and agreed to participate in the trial will be maintained, recording the date and gestational age. GBS swab results will also be recorded. We will only reveal the results from the 35 weeks' screening to the main care provider of the patient as part of the common practice. We will not provide the other screening results, neither to the patient nor to their physician.
- If a patient is found to have a positive GBS culture at 35 weeks, she will receive antibiotic treatment during labour according to the protocol.
- GBS swabs taken at delivery will be compared to previous swabs taken at an earlier gestational age in order to evaluate sensitivity, specificity, positive and negative predictive values of GBS swabs at each week of gestation and to determine the value of our primary hypothesis.
- Conditions
- GBS, Group B Streptococcal Infection
- Being tested
- genital and rectal swab
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genital and rectal swabOther
- Swabs for GBS culture should be obtained, ideally before digital examination or use of lubricants, from both the lower vagina (vaginal introitus) and rectum (insert swab through the anal sphincter) to achieve maximum sensitivity. Either two swabs (one for each site) or a single swab can be used; one swab is more cost saving. The swabs will be obtained by the patient herself after appropriate instruction or by the provider healthcare, as studies have shown equivalent sensitivity between the healthcare provider and the patient herself.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | singleton pregnancies Receives: Other: genital and rectal swab | |
| Group 2 | Twin pregnancies Receives: Other: genital and rectal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the best timing for GBS screening.
When is the best time to swab for GBS and what is the percentage of women with the same swab results at 30 or 32 weeks' gestation and at delivery
Measured: 10 weeks for each woman from the first swab to the last (at delivery)
Secondary outcomes (1)
Sensitivity, specificity, positive and negative predictive values of GBS swabs in each week of gestation
Measured: 10 weeks fpr each woman
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start1 Nov 2020 (estimated)
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Oct 2024 (estimated)
Why it stopped: This study would not add any new information
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GBSStudies 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dana Vitner MD, Rambam Health Care Campus
- Investigators
- Dana Vitner, M.D, Principal investigator, vitnerdana@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116645
- Sponsor's protocol ID
- 0251-19-RMB
- Status last verified
- Dec 2021
- First submitted
- 3 Oct 2019
- Last updated
- 13 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Frame for GBS Screening
- ClinicalTrials.gov ID
- NCT04116645
- Acronym / sponsor ID
- 0251-19-RMB
- Conditions
- GBS, Group B Streptococcal Infection
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This study would not add any new information
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 4 Oct 2019 (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.
All pregnant women prenatally being followed up or admitted at Rambam HealthCare Campus, Haifa, Israel are potential participants in the study. If a patient is agreeable, the nurse/physician/research coordinator will obtain informed consent.
Once informed consent is obtained, the patient can be swabbed for GBS. The swabs will be obtained at the routine follow-up at the clinic at 30, 32 and 35 weeks' gestation.
If a patient is found to have a positive GBS culture at 35 weeks, she will receive antibiotic treatment during labour according to the protocol.
GBS swabs taken at delivery will be compared to previous swabs taken at an earlier gestational age in order to evaluate sensitivity, specificity, positive and negative predictive values of GBS swabs at each week of gestation and to determine the value of our primary hypothesis.
Detailed description
- All pregnant women prenatally being followed up or admitted at Rambam HealthCare Campus, Haifa, Israel are potential participants in the study.
- Most high-risk pregnant women have their routine follow ups every two weeks or less from the beginning of the third trimester (between 28 and 32 weeks' gestation).
- The nurse/physician/research coordinator in the clinic will discuss the trial with those women. If a patient is agreeable, the nurse/physician/research coordinator will obtain informed consent.
- Once informed consent is obtained, the patient can be swabbed for GBS.
- The swabs will be obtained at the routine follow-up at the clinic at 30, 32 and 35 weeks' gestation. Then, they will be handed to the nurse/physician/research coordinator and transferred to the lab for analysis.
- Swabs for GBS culture should be obtained, ideally before digital examination or use of lubricants, from both the lower vagina (vaginal introitus) and rectum (insert swab through the anal sphincter) to achieve maximum sensitivity. Either two swabs (one for each site) or a single swab can be used; one swab is more cost saving. The swabs will be obtained by the patient herself after appropriate instruction as studies have shown equivalent sensitivity between the healthcare provider and the patient herself20.
- The swabs should be placed promptly into non-nutrient transport media (eg, Amies or Stuart's without charcoal) and transported at room temperature (in temperate climates) or refrigerated. The swabs are then transferred to a selective enrichment broth at a laboratory experienced in the isolation of GBS, incubated overnight at 37ºC, and subcultured onto blood agar plates. Cultures require 24 to 48 hours to show positive results. It takes 48 hours to definitively exclude GBS20.
- The swabs will be kept for seven days, then will be removed by environmental services for their discard process.
- A log of all patients who meet all inclusion criteria and agreed to participate in the trial will be maintained, recording the date and gestational age. GBS swab results will also be recorded. We will only reveal the results from the 35 weeks' screening to the main care provider of the patient as part of the common practice. We will not provide the other screening results, neither to the patient nor to their physician.
- If a patient is found to have a positive GBS culture at 35 weeks, she will receive antibiotic treatment during labour according to the protocol.
- GBS swabs taken at delivery will be compared to previous swabs taken at an earlier gestational age in order to evaluate sensitivity, specificity, positive and negative predictive values of GBS swabs at each week of gestation and to determine the value of our primary hypothesis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: genital and rectal swabsingleton pregnancies |
| Group 2 | – | Other: genital and rectal swabTwin pregnancies |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- We plan to conduct an open label prospective trial of all women with a singleton pregnancy which will be screened for GBS in four different time-points during their pregnancy, from 30 weeks' gestation up to delivery - 30, 32, 35 weeks' gestational age and at delivery.
Key inclusion criteria (2 listed)
- Pregnant women that are being followed up prenatally or admitted at Rambam HealthCare Campus, Haifa, Israel and are planning to deliver there.
- Women at gestational age 300/7 or less.
Key exclusion criteria (5 listed)
- Age 18 and under.
- Women with previous delivery of an infant affected by GBS disease.
- Women with known bacteriuria in the current pregnancy.
- Women whom are planning not to deliver at Rambam HealthCare Campus.
- Women who will not consent to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genital and rectal swab6. Swabs for GBS culture should be obtained, ideally before digital examination or use of lubricants, from both the lower vagina (vaginal introitus) and rectum (insert swab through the anal sphincter) to achieve maximum sensitivity. Either two swabs (one for each site) or a single swab can be used; one swab is more cost saving. The swabs will be obtained by the patient herself after appropriate instruction or by the provider healthcare, as studies have shown equivalent sensitivity between the healthcare provider and the patient herself. | Other | Group 1, Group 2 |
Primary outcome
Determination of the best timing for GBS screening.
Time frame: 10 weeks for each woman from the first swab to the last (at delivery)
When is the best time to swab for GBS and what is the percentage of women with the same swab results at 30 or 32 weeks' gestation and at delivery
1 secondary outcome
Sensitivity, specificity, positive and negative predictive values of GBS swabs in each week of gestation
Time frame: 10 weeks fpr each woman
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Dana Vitner, M.D principal investigator
vitnerdana@gmail.com
Questions about this trial
What is this clinical trial studying?
An observational study of GBS and Group B Streptococcal Infection, run by Rambam Health Care Campus.
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 2 inclusion and 5 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: withdrawn, as of the sponsor's last update on 13 Jan 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Determination of the best timing for GBS screening. (time frame: 10 weeks for each woman from the first swab to the last (at delivery)). 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 2022.