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.
||Observational Model: Case Control, Time Perspective: Prospective
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Accepts Healthy Volunteers|
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
1. High risk pregnancy due to: gestional diabetes, preeclampsia, small for gestational
2. Multiple gestation.
3. Pre-existing chronic illness - high blood pressure, heart disease, diabetes, lupus,
asthma, a seizure disorder, or another longstanding medical problem.