Simplified GBS Screening and Prevalence of ESBL in Pregnant Women

NCT02142933 | Completed

• 1 other identifier: EKNZ-2014-087
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Group B Streptococcal Infection; Infection Due to ESBL Bacteria

Keywords

colonization; screening; group B streptococci; extended-spectrum beta-lactamase; enterobacteriaceae

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Evaluation of pain during performance of rectal swab

  third trimester of pregnancy

• Evaluation of discomfort during performance of rectal swab

  third trimester of pregnancy

• Evaluation of stress during performance of rectal swab

  third trimester of pregnancy

• risk factors for ESBL carriage

  third trimester of pregnancy

Other Outcomes (2)

• Evaluation of costs for additional rectal swab

  between 38 and 42 gestational week

• Resistance pattern of ESBL bacteria

  between 38 and 42 gestational week

Study Arms (1)

rectal swab and vagino-perineal swab

OTHER

single-arm

Other: vagino-perineal swab

Interventions

vagino-perineal swab OTHER

rectal swab and vagino-perineal swab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Stiftung Forschung Infektionskrankheiten, Basel, Switzerland: collaborator

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Irene Hoesli, Prof.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: May 20, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: March 1, 2017
• Last Updated: July 3, 2018

Record last verified: 2018-06

Locations

CH (1)