Rapid Detection of Group B Strep- 35-37 Week Study

• ClinicalTrials.gov Identifier: NCT00331019
• Recruitment Status: Withdrawn
• First Posted: May 29, 2006
• Last Update Posted: December 15, 2015
• Sponsor: University of Michigan
• Information provided by (Responsible Party): Mark Pearlman, University of Michigan

Study Description

Brief Summary:

The purpose of this study is to determine whether a rapid bedside diagnosis of Group B Strep growing in the vagina and rectum can be performed with similar success to the routine culture.

Condition or disease
Group B Streptococcus Neonatal Sepsis

Detailed Description:

Early Onset Group B Strep (GBS) neonatal infections is one of the leading infections in newborns, nearly all of which are acquired by vertical transmission at the time of childbirth. Most cases can be prevented by identifying women who are colonized with GBS in the vaginal-rectal area and giving these colonized women prophylactic antibiotics in labor. About 15 -20% of women are colonized and nearly all of these women are asymptomatic. Because it takes up to 48 hours to obtain culture results, it is currently recommended to perform cultures in the clinic about 3 - 5 weeks prior to their due date and then prophylaxing those women colonized with GBS with antibiotics when they come in to labor. There are several downsides to this strategy. All women who present with preterm labor are treated until culture results become available (overtreatment), women who go into labor while waiting for culture results are all treated (overtreatment), prior studies have shown 33% of women are positive at 35 weeks, but negative at birth (overtreatment) and 10% are negative at 35 weeks and positive at birth (undertreatment), lost or missing culture results (over- or undertreatment). Using microfluidics and fluorescent PCR, a new test can identify GBS reliably in 30 to 45 minutes in vitro. This study proposes to evaluate the clinical performance (sensitivity, specificity, positive and negative predictive value) of the microfluidic rapid GBS technique in selected women presenting at 35 - 37 weeks to antenatal clinics at the University of Michigan compared to standard culture.

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Rapid Detection of Group B Streptococcus Using a Bedside Microfluidics Device: 35-37 Week Study
• Study Start Date: July 2006
• Actual Primary Completion Date: July 2006

Groups and Cohorts

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years or older who present for prenatal cultures in clinic at 35-37 weeks.

Criteria

Inclusion Criteria:

• Women 18 years of age or older
• Mentally capable of giving informed consent
• Presentation for regularly scheduled 35-37 week cultures

Exclusion Criteria:

• Inability to give informed consent
• Evidence of ruptured membranes by clinical or laboratory criteria
• Use of any antibiotic within the previous 7 days

Contacts and Locations

Locations

United States, Michigan

University of Michigan Hospital

Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

Investigators

• Principal Investigator: Mark D Pearlman, MD; University of Michigan, Obstetrics & Gynecology

More Information

Publications:

Boyer KM, Gotoff SP. Prevention of early-onset neonatal group B streptococcal disease with selective intrapartum chemoprophylaxis. N Engl J Med. 1986 Jun 26;314(26):1665-9.

Yancey MK, Schuchat A, Brown LK, Ventura VL, Markenson GR. The accuracy of late antenatal screening cultures in predicting genital group B streptococcal colonization at delivery. Obstet Gynecol. 1996 Nov;88(5):811-5.

Schrag S, Gorwitz R, Fultz-Butts K, Schuchat A. Prevention of perinatal group B streptococcal disease. Revised guidelines from CDC. MMWR Recomm Rep. 2002 Aug 16;51(RR-11):1-22.

Edwards RK, Clark P, Duff P. Intrapartum antibiotic prophylaxis 2: positive predictive value of antenatal group B streptococci cultures and antibiotic susceptibility of clinical isolates. Obstet Gynecol. 2002 Sep;100(3):540-4.

ACOG committee opinion. Prevention of early-onset group B streptococcal disease in newborns. Number 173--June 1996. Committee on Obstetric Practice. American College of Obstetrics and Gynecologists. Int J Gynaecol Obstet. 1996 Aug;54(2):197-205. Review.

Centers for Disease Control and Prevention (CDC). Laboratory practices for prenatal Group B streptococcal screening and reporting--Connecticut, Georgia, and Minnesota, 1997-1998. MMWR Morb Mortal Wkly Rep. 1999 May 28;48(20):426-8.

Centers for Disease Control and Prevention (CDC). Adoption of hospital policies for prevention of perinatal group B streptococcal disease--United States, 1997. MMWR Morb Mortal Wkly Rep. 1998 Aug 21;47(32):665-70.

Yancey MK, Armer T, Clark P, Duff P. Assessment of rapid identification tests for genital carriage of group B streptococci. Obstet Gynecol. 1992 Dec;80(6):1038-47. Review.

Walker CK, Crombleholme WR, Ohm-Smith MJ, Sweet RL. Comparison of rapid tests for detection of group B streptococcal colonization. Am J Perinatol. 1992 Jul;9(4):304-8.

Bergeron MG, Ke D, Ménard C, Picard FJ, Gagnon M, Bernier M, Ouellette M, Roy PH, Marcoux S, Fraser WD. Rapid detection of group B streptococci in pregnant women at delivery. N Engl J Med. 2000 Jul 20;343(3):175-9.

• Responsible Party: Mark Pearlman, S Jan Behrman Collegiate Professor of Reproductive Medicine, Professor of Obstetrics and Gynecology and Professor of Surgery, Medical School, University of Michigan
• ClinicalTrials.gov Identifier: NCT00331019
• Other Study ID Numbers: HandyLab #VVP00056
• First Posted: May 29, 2006
• Last Update Posted: December 15, 2015
• Last Verified: December 2015

Keywords provided by Mark Pearlman, University of Michigan:

Streptococcus Group B; Pregnancy

Additional relevant MeSH terms:

Neonatal Sepsis; Sepsis; Infection; Infant, Newborn, Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes