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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational

Official Title: Evaluation of a Diagnostic Kit for the Detection of Serum Antibodies Anti Genital Mycoplasma in High Risk Pregnant Women

Brief 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.

Detailed Summary:

Preterm labor and delivery are the major causes of peri-natal mortality and morbidity, accounting for 9-13% of all births, and associated with over 75% of infant mortality.

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. These bacteria are frequently found in the lower genital tract of sexually active men and women and are often considered as normal flora. However, Mycoplasma can spread and colonize the internal membranes and elicit an inflammatory response in the uterus initiating the cascade of events leading to precipitous delivery. It may also cause additional pregnancy complications such as chorioamnionitis, recurrent spontaneous abortions and postpartum endometritis.

Traditional diagnostic methods, such as microbial 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.

Studies show that colonization of the cervix or amniotic fluid alone cannot accurately predict pregnancy complications. In contrast, identification of antibodies to Mycoplasma in colonized women predicted an outstanding 85-90% of low birth weight or preterm delivery respectively.

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.

Sponsor: Promyco Diagnostics

Current Primary Outcome:

• Efficacy of the novel serology kit [ Time Frame: December 2011 ]
  Assess the efficacy of the novel serology diagnostic kit for the detection of anti-urogenital Mycoplasma antibodies in the maternal serum
• Antibody titer according to gestational age [ Time Frame: December 2011 ]
  Determine the changes in antibody titer according to gestational age both in normal and complicated pregnancies.
• Correlation between culture and serology [ Time Frame: December 2011 ]
  Determine the correlation between the antibody titer and the presence of urogenital Mycoplasma in cervix and/or amniotic fluid cultures of high risk pregnant women.
• Correlation between antibody titer and pregnancy outcome [ Time Frame: Dec 2012 ]
  Determine the correlation between maternal serum anti urogenital Mycoplasma antibody titer and pregnancy outcome in patients at risk for spontaneous preterm birth.

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Promyco Diagnostics

Dates:
Date Received: January 20, 2011
Date Started: January 2011
Date Completion: December 2012
Last Updated: January 20, 2011
Last Verified: January 2011