Clinical trial NCT01281319: Evaluation of a Serology Diagnostic Kit for the Detection of Genital Mycoplasma in Pregnancy
Official title: Evaluation of a Diagnostic Kit for the Detection of Serum Antibodies Anti Genital Mycoplasma in High Risk Pregnant Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Genital Mycoplasma Infection
High Risk Pregnancy
Preterm Labor
Keywords: preterm labor
PROM
mycoplasma
ureaplasma
high risk pregnancy
Lead sponsor: Promyco Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: Soroka University Medical Center
First posted: 2011-01-21
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal and 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 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.

Eligibility 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.

Primary outcomes:
measure: Efficacy of the novel serology kit
timeFrame: December 2011
measure: Antibody titer according to gestational age
timeFrame: December 2011
measure: Correlation between culture and serology
timeFrame: December 2011
measure: Correlation between antibody titer and pregnancy outcome
timeFrame: Dec 2012
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Sheba
country: Israel
facility: Soroka University Medical Center
Study officials:
affiliation: Soroka University Medical Center
name: Offer Erez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Horowitz S, Mazor M, Horowitz J, Porath A, Glezerman M. Antibodies to Ureaplasma urealyticum in women with intraamniotic infection and adverse pregnancy outcome. Acta Obstet Gynecol Scand. 1995 Feb;74(2):132-6. doi: 10.3109/00016349509008922.
citation: Cassell GH, Davis JK, Waites KB, Rudd PT, Talkington D, Crouse D, Horowitz SA. Pathogenesis and significance of urogenital mycoplasmal infections. Adv Exp Med Biol. 1987;224:93-115. doi: 10.1007/978-1-4684-8932-3_10.
citation: Horowitz S, Mazor M, Romero R, Horowitz J, Glezerman M. Infection of the amniotic cavity with Ureaplasma urealyticum in the midtrimester of pregnancy. J Reprod Med. 1995 May;40(5):375-9.