Genital Mycoplasma InfectionNCT01281319
Evaluation of a Serology Diagnostic Kit for the Detection of Genital Mycoplasma in Pregnancy
An observational study of Genital Mycoplasma Infection and High Risk Pregnancy, run by Promyco Diagnostics at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Genital Mycoplasma Infection, High Risk Pregnancy, Preterm Labor
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Normal and high risk pregnant women
Who may be able to join
- Women who are 18 years of age or older.
- Normal pregnancy at first trimester, or
- Women admitted with PTL, defined as the presence of regular uterine contractions associated with progressive effacement and dilatation of the uterine cervix, or
- 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
- Women admitted with chorioamnionitis, an inflammation of the fetal membranes (amnion and chorion), or
- Past pregnancy complications, including recurrent abortions, stillbirth, fetal loss, history of spontaneous preterm labor and/or delivery, or
- Recurrent abortions
Who cannot join
- High risk pregnancy due to: gestional diabetes, preeclampsia, small for gestational age fetus.
- Multiple gestation.
- Pre-existing chronic illness - high blood pressure, heart disease, diabetes, lupus, asthma, a seizure disorder, or another longstanding medical problem.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Soroka University Medical Center
Beersheba
Offer Erez, MD, offerE@clalit.org.il
Sari Sagiv, PhD, sari@promyco-diagnostics.com
About this study
Official title: 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.
Read the 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.
- Keywords
- preterm labor, PROM, mycoplasma, ureaplasma, high risk pregnancy
- Medical subject headings
- Obstetric Labor, Premature, Mycoplasma Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic normal pregnant women | Not described | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: December 2011
Antibody titer according to gestational age
Determine the changes in antibody titer according to gestational age both in normal and complicated pregnancies.
Measured: December 2011
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.
Measured: December 2011
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.
Measured: Dec 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Genital Mycoplasma InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Promyco Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Soroka University Medical Center
- Investigators
- Offer Erez, MD, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281319
- Sponsor's protocol ID
- SOR510010CTIL
- Status last verified
- Jan 2011
- First submitted
- 20 Jan 2011
- Last updated
- 21 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 7900509Cassell 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.
PubMed 3329816Horowitz 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.
PubMed 7608879
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Diagnostic Kit for the Detection of Serum Antibodies Anti Genital Mycoplasma in High Risk Pregnant Women
- ClinicalTrials.gov ID
- NCT01281319
- Acronym / sponsor ID
- SOR510010CTIL
- Keywords
- preterm labor, PROM, mycoplasma, ureaplasma, high risk pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Promyco DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- Soroka University Medical Center
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 21 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Normal and high risk pregnant women
Key inclusion criteria (7 listed)
- Women who are 18 years of age or older.
- Normal pregnancy at first trimester, or
- Women admitted with PTL, defined as the presence of regular uterine contractions associated with progressive effacement and dilatation of the uterine cervix, or
- 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
- Women admitted with chorioamnionitis, an inflammation of the fetal membranes (amnion and chorion), or
Key exclusion criteria (3 listed)
- High risk pregnancy due to: gestional diabetes, preeclampsia, small for gestational age fetus.
- Multiple gestation.
- Pre-existing chronic illness - high blood pressure, heart disease, diabetes, lupus, asthma, a seizure disorder, or another longstanding medical problem.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2011.
- Background: PubMed 7900509Horowitz 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.
- Background: PubMed 3329816Cassell 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.
- Background: PubMed 7608879Horowitz 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.
Related trials for Genital Mycoplasma Infection
Not yet recruitingPhase 4
Azithromycin for Cerclage Prophylaxis
Cervical Insufficiency
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 2
"Sexual Health Assessment of TinidaZole Against M. Genitalium (SHAZAM)"
Mycoplasma Genitalium, Non-gonococcal Urethritis (NGU)
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
RecruitingObservational study
Community Burden of MG Infection
Sexually Transmitted Infection (STI), Mycoplasma Genitalium Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Offer Erez, MD principal investigator
Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genital Mycoplasma Infection and High Risk Pregnancy, run by Promyco Diagnostics at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the novel serology kit (time frame: December 2011). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01281319, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2011.