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

January 20, 2011 updated by: Promyco Diagnostics

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

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 Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Sheba, Israel
        • Recruiting
        • Soroka University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Offer Erez, MD
        • Sub-Investigator:
          • Moshe Mazor, MD
        • Sub-Investigator:
          • Ruth Beer, MD
        • Sub-Investigator:
          • Ohad Katz, MD
        • Sub-Investigator:
          • Vered Kleitman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Normal and high risk pregnant women

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Asymptomatic normal pregnant women
Women with high risk pregnancy
Women at risk for preterm birth or recurrent abortions that are being followed at the high risk pregnancy unit (outpatients clinic, high risk day care center)
Women admitted with preterm labor
Women that are admitted to the gynecology department due to pregnancy complications: preterm labor with intact membranes (PTL) or with preterm PROM.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Promyco Diagnostics

Collaborators

Soroka University Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

January 20, 2011

First Submitted That Met QC Criteria

January 20, 2011

First Posted (Estimate)

January 21, 2011

Study Record Updates

Last Update Posted (Estimate)

January 21, 2011

Last Update Submitted That Met QC Criteria

January 20, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOR510010CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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