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Evaluation of a Serology Diagnostic Kit for the Detection of Genital Mycoplasma in Pregnancy

NCT01281319 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2011-01-21

No results posted yet for this study

Summary

Subclinical urogenital infections have been implicated in up to 70% of adverse pregnancy outcome, especially preterm labor and delivery. The most prevalent microorganisms involved in intrauterine infections are urogenital Mycoplasmas. Diagnosis by culturing or PCR merely detect the presence of the bacteria, pointing to colonized carriers only. There is no efficient and reliable diagnostic test to identify those subjects that have developed an infectious disease and are at risk of developing adverse pregnancy outcome.

In order to identify women at risk for developing pregnancy complications, Promyco Diagnostics has developed a proprietary, simple and non-invasive serology diagnostic kit for the detection of urogenital Mycoplasma infection.

Conditions

  • Genital Mycoplasma Infection
  • High Risk Pregnancy
  • Preterm Labor

Sponsors & Collaborators

  • Soroka University Medical Center

    collaborator OTHER

  • Promyco Diagnostics

    lead INDUSTRY

Principal Investigators

  • Offer Erez, MD · Soroka University Medical Center

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-12-31
Completion
2012-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01281319 on ClinicalTrials.gov