An interventional study of vagino-perineal swab in Group B Streptococcal Infection and Infection Due to ESBL Bacteria, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-03.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Diagnostic
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 250 is above the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
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Exclusion Criteria:
single-arm
Other: vagino-perineal swab
Presence of group B streptococci in genital tract
on routine visit in third trimester of pregnancy
Time frame: third trimester of pregnancy
Presence of colonizing extended-spectrum beta-lactamase enterobacteriaceae in genital tract
on routine visit in third trimester pregnancy
Time frame: third trimester of pregnancy
Evaluation of pain during performance of rectal swab
On routine visit in third trimester pregnancy
Time frame: third trimester of pregnancy
Evaluation of discomfort during performance of rectal swab
On routine visit in third trimester pregnancy
Time frame: third trimester of pregnancy
Evaluation of stress during performance of rectal swab
On routine visit in third trimester pregnancy
Time frame: third trimester of pregnancy
risk factors for ESBL carriage
on routine visit in third trimester of pregnancy
Time frame: third trimester of pregnancy
Evaluation of costs for additional rectal swab
On routine visit in third trimester pregnancy
Time frame: between 38 and 42 gestational week
Resistance pattern of ESBL bacteria
Time frame: between 38 and 42 gestational week
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland