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CompletedNCT02142933Updated Jul 3, 2018

Simplified GBS Screening and Prevalence of ESBL in Pregnant Women

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

Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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. 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.
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.

02

Conditions studied

  • Group B Streptococcal Infection
  • Infection Due to ESBL Bacteria

Keywords

  • colonization
  • screening
  • group B streptococci
  • extended-spectrum beta-lactamase
  • enterobacteriaceae
03

In context

Infections

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 →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • third trimester pregnancy
  • must attend clinic for routine screening for group B streptococcus (GBS)

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (actual)

Study arms

  • Other
    rectal swab and vagino-perineal swab

    single-arm

    Other: vagino-perineal swab

Interventions

  • Othervagino-perineal swab
06

What researchers measure

Primary outcomes

  1. Presence of group B streptococci in genital tract

    on routine visit in third trimester of pregnancy

    Time frame: third trimester of pregnancy

  2. Presence of colonizing extended-spectrum beta-lactamase enterobacteriaceae in genital tract

    on routine visit in third trimester pregnancy

    Time frame: third trimester of pregnancy

Secondary outcomes

  1. Evaluation of pain during performance of rectal swab

    On routine visit in third trimester pregnancy

    Time frame: third trimester of pregnancy

  2. Evaluation of discomfort during performance of rectal swab

    On routine visit in third trimester pregnancy

    Time frame: third trimester of pregnancy

  3. Evaluation of stress during performance of rectal swab

    On routine visit in third trimester pregnancy

    Time frame: third trimester of pregnancy

  4. risk factors for ESBL carriage

    on routine visit in third trimester of pregnancy

    Time frame: third trimester of pregnancy

Other outcomes

  1. Evaluation of costs for additional rectal swab

    On routine visit in third trimester pregnancy

    Time frame: between 38 and 42 gestational week

  2. Resistance pattern of ESBL bacteria

    Time frame: between 38 and 42 gestational week

07

Study locations

1 site
  • University Hospital Basel
    Basel, 4031, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02142933
Lead sponsor
University Hospital, Basel, Switzerland
Collaborators
Stiftung Forschung Infektionskrankheiten, Basel, Switzerland
Responsible party
Sponsor
First posted
May 20, 2014
Start date
Nov 2014
Primary completion
Nov 2016
Completion
Mar 2017
Last update
Jul 3, 2018

Study contacts

Irene Hoesli, Prof.
principal investigator · University Hospital, Basel, Switzerland
View the source record on ClinicalTrials.gov ↗

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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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