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

This study is currently Recruiting

January 2011 By Promyco Diagnostics

First Recieved on January 20, 2011

Last Updated on January 20, 2011

Sponsor: Promyco Diagnostics
Collaborators: Soroka University Medical Center
Information provided by: Promyco Diagnostics
Identifier: NCT01281319

Purpose

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.

Study Type: Observational
Study Design: Observational Model: Case Control, Time Perspective: Prospective

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Female
Accepts Healthy Volunteers:Accepts Healthy Volunteers
Criteria

Inclusion Criteria: 1. Women who are 18 years of age or older. 2. Normal pregnancy at first trimester, or 3. Women admitted with PTL, defined as the presence of regular uterine contractions associated with progressive effacement and dilatation of the uterine cervix, or 4. Women admitted with PROM, defined as rupture of the chorioamniotic membranes before the onset of labor and diagnosed by sterile speculum examination confirming pooling of amniotic fluid in the vagina, positive nitrazine test or incase of diagnostic amniocentesis leakage of indigocarmine through the uterine cervix, or 5. Women admitted with chorioamnionitis, an inflammation of the fetal membranes (amnion and chorion), or 6. Past pregnancy complications, including recurrent abortions, stillbirth, fetal loss, history of spontaneous preterm labor and/or delivery, or 7. Recurrent abortions Exclusion Criteria: 1. High risk pregnancy due to: gestional diabetes, preeclampsia, small for gestational age fetus. 2. Multiple gestation. 3. Pre-existing chronic illness - high blood pressure, heart disease, diabetes, lupus, asthma, a seizure disorder, or another longstanding medical problem.

Investigators

  • Investigator: Offer Erez, MD - Principal Investigator - Soroka University Medical Center

Locations

  • Soroka University Medical Center

    Beer Sheba, Israel

Conditions related to this trial:

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