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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Promyco Diagnostics.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Soroka University Medical Center
Information provided by:
Promyco Diagnostics
ClinicalTrials.gov Identifier:
NCT01281319
First received: January 20, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition
Genital Mycoplasma Infection
High Risk Pregnancy
Preterm Labor

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of a Diagnostic Kit for the Detection of Serum Antibodies Anti Genital Mycoplasma in High Risk Pregnant Women

Further study details as provided by Promyco Diagnostics:

Primary Outcome Measures:
  • Efficacy of the novel serology kit [ Time Frame: December 2011 ] [ Designated as safety issue: No ]
    Assess the efficacy of the novel serology diagnostic kit for the detection of anti-urogenital Mycoplasma antibodies in the maternal serum

  • Antibody titer according to gestational age [ Time Frame: December 2011 ] [ Designated as safety issue: No ]
    Determine the changes in antibody titer according to gestational age both in normal and complicated pregnancies.

  • Correlation between culture and serology [ Time Frame: December 2011 ] [ Designated as safety issue: No ]
    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.

  • Correlation between antibody titer and pregnancy outcome [ Time Frame: Dec 2012 ] [ Designated as safety issue: No ]
    Determine the correlation between maternal serum anti urogenital Mycoplasma antibody titer and pregnancy outcome in patients at risk for spontaneous preterm birth.


Biospecimen Retention:   Samples With DNA

Cervix swab, amniotic fluid and serum samples


Estimated Enrollment: 300
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Normal and high risk pregnant women

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281319

Locations
Israel
Soroka University Medical Center Recruiting
Beer Sheba, Israel
Contact: Offer Erez, MD       offerE@clalit.org.il   
Contact: Sari Sagiv, PhD       sari@promyco-diagnostics.com   
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         
Sponsors and Collaborators
Promyco Diagnostics
Soroka University Medical Center
Investigators
Principal Investigator: Offer Erez, MD Soroka University Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Dr Offer Erez, Soroka Medical Center
ClinicalTrials.gov Identifier: NCT01281319     History of Changes
Other Study ID Numbers: SOR510010CTIL
Study First Received: January 20, 2011
Last Updated: January 20, 2011
Health Authority: Israel: Clalit Health Services

Keywords provided by Promyco Diagnostics:
preterm labor
PROM
mycoplasma
ureaplasma
high risk pregnancy

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pleuropneumonia
Mycoplasma Infections
Pregnancy Complications
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Pleurisy
Pleural Diseases
Respiratory Tract Infections
Mycoplasmatales Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on October 01, 2014