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

• Conditions: High Risk Pregnancy; Preterm Labor; Genital Mycoplasma Infection

• Registration Number: NCT01281319
• Lead Sponsor: Promyco Diagnostics

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.

Study Timeline

• Status Verified: 2011-01
• Study Start: 2011-01
• Study First Submitted: 2011-01-20
• Study First Submitted QC: 2011-01-20
• Last Update Submitted: 2011-01-20
• Study First Posted: 2011-01-21
• Last Update Posted: 2011-01-21
• Primary Completion: 2011-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of the novel serology kit	December 2011	Assess the efficacy of the novel serology diagnostic kit for the detection of anti-urogenital Mycoplasma antibodies in the maternal serum
Correlation between antibody titer and pregnancy outcome	Dec 2012	Determine the correlation between maternal serum anti urogenital Mycoplasma antibody titer and pregnancy outcome in patients at risk for spontaneous preterm birth.
Antibody titer according to gestational age	December 2011	Determine the changes in antibody titer according to gestational age both in normal and complicated pregnancies.
Correlation between culture and serology	December 2011	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.

Trial Locations

Locations (1)

Soroka University Medical Center; 🇮🇱 Beer Sheba, Israel