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

Preterm Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01281319
• Other study ID #: SOR510010CTIL
• Status: Recruiting
• Phase: N/A
• First received: January 20, 2011
• Last updated: January 20, 2011
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2011
• Source: Promyco Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Genital Mycoplasma Infection
• High Risk Pregnancy
• Mycoplasma Infections
• Obstetric Labor, Premature
• Pleuropneumonia
• Preterm Labor

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Beer Sheba

Sponsors (2)

Lead Sponsor	Collaborator
Promyco Diagnostics	Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of the novel serology kit	Assess the efficacy of the novel serology diagnostic kit for the detection of anti-urogenital Mycoplasma antibodies in the maternal serum	December 2011	No
Primary	Antibody titer according to gestational age	Determine the changes in antibody titer according to gestational age both in normal and complicated pregnancies.	December 2011	No
Primary	Correlation between culture and serology	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.	December 2011	No
Primary	Correlation between antibody titer and pregnancy outcome	Determine the correlation between maternal serum anti urogenital Mycoplasma antibody titer and pregnancy outcome in patients at risk for spontaneous preterm birth.	Dec 2012	No

External Links

•   Promyco Diagnostics web site