NCT00331019

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Last Updated

December 15, 2015

Status Verified

December 1, 2015

Enrollment Period

Same day

First QC Date

May 26, 2006

Last Update Submit

December 14, 2015

Conditions

Group B Streptococcus Neonatal Sepsis

Keywords

Streptococcus Group BPregnancy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (10)

  • 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.

    PMID: 3520319BACKGROUND

  • 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.

    PMID: 8885919BACKGROUND

  • 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.

    PMID: 12211284BACKGROUND

  • 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.

    PMID: 12220775BACKGROUND

  • 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.

    PMID: 9236325BACKGROUND

  • 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.

    PMID: 10365633BACKGROUND

  • 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.

    PMID: 9729032BACKGROUND

  • 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.

    PMID: 1448249BACKGROUND

  • 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.

    PMID: 1627226BACKGROUND

  • 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.

    PMID: 10900276BACKGROUND

Study Officials

  • Mark D Pearlman, MD

    University of Michigan, Obstetrics & Gynecology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
S Jan Behrman Collegiate Professor of Reproductive Medicine, Professor of Obstetrics and Gynecology and Professor of Surgery, Medical School

Study Record Dates

First Submitted

May 26, 2006

First Posted

May 29, 2006

Study Start

July 1, 2006

Primary Completion

July 1, 2006

Last Updated

December 15, 2015

Record last verified: 2015-12

Locations

US(1)