- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00330642
Rapid Detection of Group B Streptococcus (Strep)-Labor and Delivery Study
14. desember 2015 oppdatert av: Mark Pearlman, University of Michigan
Rapid Detection of Group B Streptococcus Using a Bedside Microfluidics Device: Labor and Delivery Study
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.
Studieoversikt
Status
Tilbaketrukket
Forhold
Detaljert beskrivelse
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).
Studietype
Observasjonsmessig
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109
- University of Michigan Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients 18 years or older who present for induction of labor.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Mark D Pearlman, MD, University of Michigan, Obstetrics and Gynecology
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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. doi: 10.1056/NEJM198606263142603.
- 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.
- 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. doi: 10.1016/s0029-7844(02)02097-5.
- 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.
- 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.
- 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.
- 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. doi: 10.1055/s-2007-999247.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2006
Primær fullføring (Faktiske)
1. juli 2006
Datoer for studieregistrering
Først innsendt
26. mai 2006
Først innsendt som oppfylte QC-kriteriene
26. mai 2006
Først lagt ut (Anslag)
29. mai 2006
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
15. desember 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. desember 2015
Sist bekreftet
1. desember 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HandyLab #VVP00103
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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