Clinical trial NCT00331019: Rapid Detection of Group B Strep- 35-37 Week Study
Official title: Rapid Detection of Group B Streptococcus Using a Bedside Microfluidics Device: 35-37 Week Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Group B Streptococcus Neonatal Sepsis
Keywords: Streptococcus Group B
Pregnancy
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2006-05-29
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18 years or older who present for prenatal cultures in clinic at 35-37 weeks.

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.

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan, Obstetrics & Gynecology
name: Mark D Pearlman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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. doi: 10.1016/0029-7844(96)00320-1.
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citation: 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. No abstract available.
citation: 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.
citation: 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.
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citation: Bergeron MG, Ke D, Menard 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. doi: 10.1056/NEJM200007203430303.