Group B Streptococcal Infection Clinical Trial
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
NCT number | NCT02142933 |
Other study ID # | EKNZ-2014-087 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2014 |
Est. completion date | March 2017 |
Verified date | June 2018 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. 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.
2. 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.
Status | Completed |
Enrollment | 250 |
Est. completion date | March 2017 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - third trimester pregnancy - must attend clinic for routine screening for group B streptococcus (GBS) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Basel | Basel |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland | Stiftung Forschung Infektionskrankheiten, Basel, Switzerland |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Evaluation of costs for additional rectal swab | On routine visit in third trimester pregnancy | between 38 and 42 gestational week | |
Other | Resistance pattern of ESBL bacteria | between 38 and 42 gestational week | ||
Primary | Presence of group B streptococci in genital tract | on routine visit in third trimester of pregnancy | third trimester of pregnancy | |
Primary | Presence of colonizing extended-spectrum beta-lactamase enterobacteriaceae in genital tract | on routine visit in third trimester pregnancy | third trimester of pregnancy | |
Secondary | Evaluation of pain during performance of rectal swab | On routine visit in third trimester pregnancy | third trimester of pregnancy | |
Secondary | Evaluation of discomfort during performance of rectal swab | On routine visit in third trimester pregnancy | third trimester of pregnancy | |
Secondary | Evaluation of stress during performance of rectal swab | On routine visit in third trimester pregnancy | third trimester of pregnancy | |
Secondary | risk factors for ESBL carriage | on routine visit in third trimester of pregnancy | third trimester of pregnancy |
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