Rapid Diagnostic Test for Detection of Group B Streptococcus in Pregnancy (GBS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jonathan P Faro, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01445717
First received: September 30, 2011
Last updated: May 2, 2013
Last verified: May 2013
  Purpose

This study evaluates the use of a new method of growing and detecting Group B streptococcus in pregnant women. This new method utilizes sandwiched-membrane petri technology and has the advantage of detecting GBS in less than 6 hours, with less cost, and the potential of allowing antibiotic sensitivities to be performed.


Condition
Streptococcus Infection
Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of a New Rapid Method, BioNanoPore, for Growth and Detection of Group B Streptococcus in Pregnant Patients

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Culture of Group B streptococcus [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Rapid assay results will be compared to routine culture results.


Biospecimen Retention:   Samples Without DNA

Specimens are to be retained for one month, frozen in LIM broth, and will be held for use if reprocessing specimens is required.


Enrollment: 358
Study Start Date: November 2010
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Intrapartum infection with group B streptococci (GBS) may lead to untoward neonatal sequelae such as pneumonia, septicemia, and meningitis. Several clinical trials have demonstrated that the use of intrapartum intravenous antibiotic prophylaxis (with penicillin being the agent of choice due to a narrower spectrum of antimicrobial activity) is highly effective to prevent early-onset neonatal GBS infections. It has been estimated that 10% to 30% of all pregnant women are GBS carriers, and it is likely that GBS colonizes virtually every female at some point. Consensus guidelines from the Centers for Disease Control and Prevention (CDC), American College of Obstetricians and Gynecologists (ACOG), and the American Academy of Pediatrics, recommend prenatal screening at 35 to 37 weeks of gestation and chemoprophylaxis at delivery based upon this culture result. The CDC-recommended method for detecting GBS colonization involves collecting a combined vaginal and rectal specimen and culturing the organism in a selective broth medium, followed be subculturing onto blood agar plates.

However, this traditional method of culture takes up to 72 hours for results to be available. With 12.8% of patients experiencing a preterm delivery prior to when a GBS screening occurs, and up to 15% of term pregnancies not having routine GBS screening performed, a significant portion of women present with unknown GBS status at the time of potential delivery. These clinical situations require obstetricians to utilize a risk-based strategy that has been shown to be only half as effective as culture-based screening. Thus, a need exists for a rapid detection method for GBS.

Recent research has focused on polymerase chain reaction (PCR) based methods for detection of GBS. Sensitivity for detection of GBS by the PCR assay has ranged from 87% to 91%. These methods are limited by high cost, and inability to perform antibiotic sensitivities for GBS (in women with a penicillin allergy). New technologies, called bionanopore (BNP) and bionanofilter (BNF) are rapid, microbial detection systems that utilizes sandwiched-membrane petri technology. These have the advantage of detecting GBS in less than 6 hours, with less cost, and the potential of allowing antibiotic sensitivities to be performed.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant patients who present to the UT resident or attending clinic between 35-37 weeks for routine follow-up will be asked to enroll.

Criteria

Inclusion Criteria:

  • > 18 years
  • 35-37 weeks pregnancy
  • Patient receiving prenatal care at UT Houston Hermann Memorial OB/Gyn resident or attending clinic.

Exclusion Criteria:

  • Pt elects not to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01445717

Locations
United States, Texas
UTHSC at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Jonathan Faro, MD The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: Jonathan P Faro, Assistant Professor, ObGyn, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01445717     History of Changes
Other Study ID Numbers: HSC-MS-10-0317
Study First Received: September 30, 2011
Last Updated: May 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center, Houston:
GBS, Streptococcus, .
Group B

Additional relevant MeSH terms:
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on October 16, 2014