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

NCT01281319 | Unknown

• 1 other identifier: SOR510010CTIL
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Genital Mycoplasma Infection; High Risk Pregnancy; Preterm Labor

Keywords

preterm labor; PROM; mycoplasma; ureaplasma; high risk pregnancy

Outcome Measures

Primary Outcomes (4)

• 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

• Antibody titer according to gestational age

  Determine the changes in antibody titer according to gestational age both in normal and complicated pregnancies.

  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.

  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.

  Dec 2012

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Normal and high risk pregnant women

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Promyco Diagnostics: lead
• Soroka University Medical Center: collaborator

Study Sites (1)

Soroka University Medical Center

Beersheba, Israel

RECRUITING

Related Publications (3)

• 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.

  PMID: 7900509 BACKGROUND

• 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. doi: 10.1007/978-1-4684-8932-3_10.

  PMID: 3329816 BACKGROUND

• 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.

  PMID: 7608879 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Cervix swab, amniotic fluid and serum samples

MeSH Terms

Conditions

Obstetric Labor, Premature; Mycoplasma Infections

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mycoplasmatales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Offer Erez, MD

  Soroka University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 20, 2011
• First Posted: January 21, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: January 21, 2011

Record last verified: 2011-01

Locations

IL (1)