Group B Streptococcal InfectionNCT02142933
Simplified GBS Screening and Prevalence of ESBL in Pregnant Women
A study testing vagino-perineal swab in people with Group B Streptococcal Infection and Infection Due to ESBL Bacteria, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
1. At the University Hospital Basel, Switzerland, a simplified screening for group B streptococci (GBS) of vagina and perineum has been performed since several years. Reliable detection of GBS is critical to prevent GBS transmission during delivery with antimicrobial prophylaxis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Group B Streptococcal Infection, Infection Due to ESBL Bacteria
- What is being tested?
- vagino-perineal swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2014to Mar 2017
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- third trimester pregnancy
- must attend clinic for routine screening for group B streptococcus (GBS)
Who cannot join
- detection of group B streptococcus in urine
- history of neonatal group B streptococcal sepsis in previous pregnancy
- antibiotic treatment within the past 2 weeks before routine GBS screening
- delivery < 37 gestational week
- condition or disorders suggestive for urinary tract infection, genital tract infection, or bacterial vaginosis
- language barrier (insufficient knowledge of German or English)
- the expected mother has any other condition, that, in the opinion of the investigator or treating physician, would jeopardize the safety or rights of the expected mother participating in the study, or would confound the results of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 1) Accuracy of the Vagino-perineal Versus the Standard Dual Swab for Detection of Group B Streptococcus in Pregnancy 2) Prevalence and Risk Factors of Extended-Spectrum Beta-Lactamase Producing Enterobacteriaceae in Pregnancy
- At the University Hospital Basel, Switzerland, a simplified screening for group B streptococci (GBS) of vagina and perineum has been performed since several years. Reliable detection of GBS is critical to prevent GBS transmission during delivery with antimicrobial prophylaxis. Transmission of GBS to the neonate may otherwise lead to severe infection and complications in the neonate. Centers for Disease Control and Prevention (CDC) and other international organizations recommend a vaginal and additional rectal swab.We therefore aim to test this simplified screening against the international gold standard.
- Antibiotic resistant bacteria may reside in the genital tract of an expected mother and may be transmitted to the new-born during delivery. In case of infection of the pregnant woman or the neonate, application of standard antimicrobial treatment will insufficiently cover these extended spectrum beta-lactamase (ESBL) producing bacteria. Therefore, colonization with ESBL in pregnancy needs to be known to potentially deliver adequate antimicrobial treatment.
Read the detailed description
Transmission of GBS under delivery leads in 1/1000 of live births to severe sepsis in the neonate and may have serious sequelae including death. Most of the cases concern early onset sepsis which occurs in the first three to seven days after birth. Several randomized studies showed that antibiotic prophylaxis during delivery reduces the risk of early onset sepsis in the neonate in 85%, whereas late onset sepsis was not affected. Accurate screening including appropriate culture methods are critical for the wealth of the newborn and the decision regarding application of antibiotic prophylaxis to the mother. In this study we compare a simplified test algorithm taking swabs from the vagina and the perineum only versus a combined vaginal and rectal swab for GBS culture which is the current gold standard of diagnosis as the culture yield for GBS increases substantially when samples are taken from both the lower vagina and the rectum compared to swabbing the vagina or endocervix only. There is certain reluctance for performing a rectal swab as it has been associated with discomfort.
The study aims to demonstrate that this simplified vagino-perineal swab leads to a similar GBS detection rate as compared to the gold standard comprising of a combined vaginal and rectal swab. We further aim to systematically assess the degree of discomfort with the rectal swab and compare the costs when applying those different methods.
Additionally we aim to determine the prevalence and risk factors of community acquired ESBL by further processing the swabs in the appropriate culture media and filling in a standardized questionnaire.
We plan a prospective cohort study with inclusion of 450 pregnant women who attend the outpatient obstetric clinic for routine control in the third trimester.
- Being tested
- vagino-perineal swab
- Keywords
- colonization, screening, group B streptococci, extended-spectrum beta-lactamase, enterobacteriaceae
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vagino-perineal swabOther
| Study group | Role | What they receive |
|---|---|---|
| rectal swab and vagino-perineal swab | Other | single-arm Receives: Other: vagino-perineal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of group B streptococci in genital tract
on routine visit in third trimester of pregnancy
Measured: third trimester of pregnancy
Presence of colonizing extended-spectrum beta-lactamase enterobacteriaceae in genital tract
on routine visit in third trimester pregnancy
Measured: third trimester of pregnancy
Secondary outcomes (4)
Evaluation of pain during performance of rectal swab
On routine visit in third trimester pregnancy
Measured: third trimester of pregnancy
Evaluation of discomfort during performance of rectal swab
On routine visit in third trimester pregnancy
Measured: third trimester of pregnancy
Evaluation of stress during performance of rectal swab
On routine visit in third trimester pregnancy
Measured: third trimester of pregnancy
risk factors for ESBL carriage
on routine visit in third trimester of pregnancy
Measured: third trimester of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Group B Streptococcal InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Stiftung Forschung Infektionskrankheiten, Basel, Switzerland
- Responsible party
- Sponsor
- Investigators
- Irene Hoesli, Prof., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142933
- Sponsor's protocol ID
- EKNZ-2014-087
- Status last verified
- Jun 2018
- First submitted
- 16 May 2014
- Last updated
- 3 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1) Accuracy of the Vagino-perineal Versus the Standard Dual Swab for Detection of Group B Streptococcus in Pregnancy 2) Prevalence and Risk Factors of Extended-Spectrum Beta-Lactamase Producing Enterobacteriaceae in Pregnancy
- ClinicalTrials.gov ID
- NCT02142933
- Acronym / sponsor ID
- EKNZ-2014-087
- Keywords
- colonization, screening, group B streptococci, extended-spectrum beta-lactamase, enterobacteriaceae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Stiftung Forschung Infektionskrankheiten, Basel, Switzerland
- Study start
- Nov 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 20 May 2014 (estimated)
- 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.
- At the University Hospital Basel, Switzerland, a simplified screening for group B streptococci (GBS) of vagina and perineum has been performed since several years. Reliable detection of GBS is critical to prevent GBS transmission during delivery with antimicrobial prophylaxis. Transmission of GBS to the neonate may otherwise lead to severe infection and complications in the neonate. Centers for Disease Control and Prevention (CDC) and other international organizations recommend a vaginal and additional rectal swab.We therefore aim to test this simplified screening against the international gold standard.
- Antibiotic resistant bacteria may reside in the genital tract of an expected mother and may be transmitted to the new-born during delivery. In case of infection of the pregnant woman or the neonate, application of standard antimicrobial treatment will insufficiently cover these extended spectrum beta-lactamase (ESBL) producing bacteria. Therefore, colonization with ESBL in pregnancy needs to be known to potentially deliver adequate antimicrobial treatment.
Detailed description
Transmission of GBS under delivery leads in 1/1000 of live births to severe sepsis in the neonate and may have serious sequelae including death. Most of the cases concern early onset sepsis which occurs in the first three to seven days after birth. Several randomized studies showed that antibiotic prophylaxis during delivery reduces the risk of early onset sepsis in the neonate in 85%, whereas late onset sepsis was not affected. Accurate screening including appropriate culture methods are critical for the wealth of the newborn and the decision regarding application of antibiotic prophylaxis to the mother. In this study we compare a simplified test algorithm taking swabs from the vagina and the perineum only versus a combined vaginal and rectal swab for GBS culture which is the current gold standard of diagnosis as the culture yield for GBS increases substantially when samples are taken from both the lower vagina and the rectum compared to swabbing the vagina or endocervix only. There is certain reluctance for performing a rectal swab as it has been associated with discomfort.
The study aims to demonstrate that this simplified vagino-perineal swab leads to a similar GBS detection rate as compared to the gold standard comprising of a combined vaginal and rectal swab. We further aim to systematically assess the degree of discomfort with the rectal swab and compare the costs when applying those different methods.
Additionally we aim to determine the prevalence and risk factors of community acquired ESBL by further processing the swabs in the appropriate culture media and filling in a standardized questionnaire.
We plan a prospective cohort study with inclusion of 450 pregnant women who attend the outpatient obstetric clinic for routine control in the third trimester.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rectal swab and vagino-perineal swab | Other | Other: vagino-perineal swabsingle-arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- third trimester pregnancy
- must attend clinic for routine screening for group B streptococcus (GBS)
Key exclusion criteria (7 listed)
- detection of group B streptococcus in urine
- history of neonatal group B streptococcal sepsis in previous pregnancy
- antibiotic treatment within the past 2 weeks before routine GBS screening
- delivery < 37 gestational week
- condition or disorders suggestive for urinary tract infection, genital tract infection, or bacterial vaginosis
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 |
|---|---|---|
| vagino-perineal swab | Other | rectal swab and vagino-perineal swab |
Primary outcome
Presence of group B streptococci in genital tract
Time frame: third trimester of pregnancy
on routine visit in third trimester of pregnancy
Presence of colonizing extended-spectrum beta-lactamase enterobacteriaceae in genital tract
Time frame: third trimester of pregnancy
on routine visit in third trimester pregnancy
4 secondary outcomes
Evaluation of pain during performance of rectal swab
Time frame: third trimester of pregnancy
Evaluation of discomfort during performance of rectal swab
Time frame: third trimester of pregnancy
Evaluation of stress during performance of rectal swab
Time frame: third trimester of pregnancy
risk factors for ESBL carriage
Time frame: third trimester of pregnancy
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 3 Jul 2018.
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Group B Streptococcal Infections
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.
Irene Hoesli, Prof. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vagino-perineal swab in people with Group B Streptococcal Infection and Infection Due to ESBL Bacteria, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 7 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 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Presence of group B streptococci in genital tract (time frame: third trimester of pregnancy). The study lists 2 primary outcomes in all. 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 3 Jul 2018.