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Completed

NCT Number: NCT03585023

Infections and Pregnancy Loss: Correlation Between Abortion and Silent Infections.

Correlation between the presence of intracellular viruses/bacteria and the incidence of miscarriage during the first trimester of pregnancy.

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Key information

Conditions

Age range

18 year–42 year

Sex eligibility

Female

Study type

Observational

About this study

In this study we will analyse chorionic villi derived from abortion during the first trimester of pregnancy (spontaneous abortion vs voluntary pregnancy interruption), in order to correlate the presence of infective viruses/bacteria and the incidence of miscarriage.

The first objective of this project will be to find the viral DNA of HPV, BK and JC polyomaviruses and bacterial DNA of Chlamydia trachomatis, Ureaplasma parvum, Ureaplasma urealyticum, Mycoplasma hominis in the aborted tissues collected from spontaneous abortions, and to compare the prevalence of these DNAs to those derived from elective specimens.

Acronyms:

DNA: deoxyribonucleic acid HPV: human papillomavirus PCR: polymerase chain reaction HPyV: human polyomavirus PBMC: peripheral blood mononucleated cell BKV: BK polyomavirus JCV: JC polyomavirus

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

I.Inclusion and exclusion criteria

Inclusion criteria

  • age of the patients range from 18 to 42 years old;
  • gestational age ranging in the first 12 weeks.

Exclusion criteria

  • medical history or laboratory tests positive for sexually transmitted diseases (HIV, HBV, HCV, LUE) during the last year;
  • Congenital or Acquired Immunodeficiency diseases, or immunosuppressive therapies during the last year;
  • Therapeutic abortion (voluntary interruption of pregnancy, law 194 art 6 comma b)
  • well known causes responsable for spontaneous abortions such as genetic, severe uterine or hormonal abnormalities and use of teratogenic drugs.

Treatment and study plan

Spontaneous miscarriage

Diagnostic Test

Viral DNA and RNA analysis of HPyV and HPV, BKV and JCV. Bacterial DNA and RNA analysis of Chlamydia trachomatis, Ureaplasma parvum, U. urealyticum, Mycoplasma hominis.

Voluntary pregnancy interruption

Diagnostic Test

Viral DNA and RNA analysis of HPyV and HPV, BKV and JCV. Bacterial DNA and RNA analysis of Chlamydia trachomatis, Ureaplasma parvum, U. urealyticum, Mycoplasma hominis.

Primary outcomes

  1. Individuation of DNA of intracellular agents (viral und bacterial) in chorionic tissue und blood sample.

    Time frame: December 2014 - April 2017

    The primary outcome of this project is to find the DNA of viral (HPV, HPyV,BK and JC), or bacterial agents (Chlamydia trachomatis, Ureaplasma parvum, U. urealyticum, Mycoplasma hominis) in samples obtained from spontaneous abortion or elective interruption of pregnancy.

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Official study title

Silent Intracellular Infections and Early Pregnancy Loss

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jul 12, 2018
Registry last updated
Jul 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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