MedDataX Logo

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

NCT ID: NCT00331019

Last Updated: 2015-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Group B Streptococcus Neonatal Sepsis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Streptococcus Group B Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mark Pearlman

S Jan Behrman Collegiate Professor of Reproductive Medicine, Professor of Obstetrics and Gynecology and Professor of Surgery, Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mark D Pearlman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan, Obstetrics & Gynecology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Michigan Hospital

Ann Arbor, Michigan, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 3520319 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8885919 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12211284 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12220775 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9236325 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10365633 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9729032 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1448249 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1627226 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10900276 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HandyLab #VVP00056

Identifier Type: -

Identifier Source: org_study_id