NCT01281319

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Promyco Diagnostics · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Genital Mycoplasma Infection
• High Risk Pregnancy
• Preterm Labor

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-12-01
• Completion: 2012-12-01
• First posted: 2011-01-21
• Last updated: 2011-01-21

Locations

1 site across 1 country: Israel