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| Name | Class |
|---|---|
| Stiftung Forschung Infektionskrankheiten, Basel, Switzerland | UNKNOWN |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rectal swab and vagino-perineal swab | Other | single-arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vagino-perineal swab | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of group B streptococci in genital tract | on routine visit in third trimester of pregnancy | third trimester of pregnancy |
| Presence of colonizing extended-spectrum beta-lactamase enterobacteriaceae in genital tract | on routine visit in third trimester pregnancy | third trimester of pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of pain during performance of rectal swab | On routine visit in third trimester pregnancy | third trimester of pregnancy |
| Evaluation of discomfort during performance of rectal swab | On routine visit in third trimester pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of costs for additional rectal swab | On routine visit in third trimester pregnancy | between 38 and 42 gestational week |
| Resistance pattern of ESBL bacteria | between 38 and 42 gestational week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irene Hoesli, Prof. | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| third trimester of pregnancy |
| Evaluation of stress during performance of rectal swab | On routine visit in third trimester pregnancy | third trimester of pregnancy |
| risk factors for ESBL carriage | on routine visit in third trimester of pregnancy | third trimester of pregnancy |