Rapid Detection of Group B Streptococcus (Strep)-Labor and Delivery Study

Streptococcal Infections Clinical Trial

Official title:

Rapid Detection of Group B Streptococcus Using a Bedside Microfluidics Device: Labor and Delivery Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00330642
• Other study ID #: HandyLab #VVP00103
• Status: Withdrawn
• Phase: N/A
• First received: May 26, 2006
• Last updated: December 14, 2015
• Start date: July 2006

Study information

• Verified date: December 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether a rapid bedside diagnosis of group B strep (GBS) growing in the vagina and rectum can be performed with similar success to the routine culture in women who are in labor.

Description:

Group B Strep neonatal infections is one of the leading infections in newborns, most 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 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 5 weeks prior to their due date and then treat those with GBS when they come in for 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 un-selected sequential women presenting to labor and delivery, comparing them to cultures taken at the same time and the 35-37 week cultures in these same women. We will also evaluate the identification of GBS before and after rupture of membranes (amniotomy) using both standard GBS culture and rapid PCR (HandyLab technology).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women 18 years of age or older

• Mentally capable of giving informed consent

• Symptoms and signs at presentation related to possible labor or ruptured membranes (leakage of fluid, uterine contractions, pelvic pressure)

• Presentation for induction of labor irrespective of cause

Exclusion Criteria:

• Inability to give informed consent

• Conditions where the time taken to obtain specimens are potentially harmful to one or one's baby (heavy bleeding, low fetal heart rate, preterm premature rupture of membranes)

• Use of any antibacterials within the previous 7 days

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Streptococcal Infections

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View Citation