Rapid Detection of Group B Strep- 35-37 Week Study
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ClinicalTrials.gov Identifier: NCT00331019 |
Recruitment Status :
Withdrawn
(HandyLab device determined to not work for the science)
First Posted : May 29, 2006
Last Update Posted : December 15, 2015
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Condition or disease |
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Group B Streptococcus Neonatal Sepsis |
Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Rapid Detection of Group B Streptococcus Using a Bedside Microfluidics Device: 35-37 Week Study |
Study Start Date : | July 2006 |
Actual Primary Completion Date : | July 2006 |

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331019
United States, Michigan | |
University of Michigan Hospital | |
Ann Arbor, Michigan, United States, 48109 |
Principal Investigator: | Mark D Pearlman, MD | University of Michigan, Obstetrics & Gynecology |
Responsible Party: | Mark Pearlman, S Jan Behrman Collegiate Professor of Reproductive Medicine, Professor of Obstetrics and Gynecology and Professor of Surgery, Medical School, University of Michigan |
ClinicalTrials.gov Identifier: | NCT00331019 |
Other Study ID Numbers: |
HandyLab #VVP00056 |
First Posted: | May 29, 2006 Key Record Dates |
Last Update Posted: | December 15, 2015 |
Last Verified: | December 2015 |
Streptococcus Group B Pregnancy |
Neonatal Sepsis Sepsis Infection Infant, Newborn, Diseases |
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |