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

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ClinicalTrials.gov Identifier: NCT03585023
Recruitment Status : Completed
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Angela Graziano, University Hospital of Ferrara

Study Description
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Brief Summary:
Correlation between the presence of intracellular viruses/bacteria and the incidence of miscarriage during the first trimester of pregnancy.

Condition or disease Intervention/treatment
Pregnancy Loss Diagnostic Test: Spontaneous miscarriage Diagnostic Test: Voluntary pregnancy interruption

Detailed Description:

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

Study Design
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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Silent Intracellular Infections and Early Pregnancy Loss
Actual Study Start Date : November 15, 2014
Actual Primary Completion Date : November 15, 2016
Actual Study Completion Date : May 14, 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Spontaneous miscarriage
The study group will be recruited at admission for uterine cavity revision planned for spontaneous abortion.
 Diagnostic Test: Spontaneous miscarriage
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.

Diagnostic Test: Voluntary pregnancy interruption
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
The control group will be recruited at admission for uterine cavity revision planned for voluntary pregnancy interruption.
 Diagnostic Test: Spontaneous miscarriage
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.

Diagnostic Test: Voluntary pregnancy interruption
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.


Outcome Measures
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Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA

All samples, both spontaneous (spontaneous miscarriage) and elective (voluntary interruption of pregnancy), will be obtained after uterine cavity curettage.

All women underwent PBMC extraction from peripheral whole blood.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women who underwent revision of uterine cavity for spontaneous abortion or voluntary termination of pregnancy
Criteria

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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Angela Graziano, Doctor, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT03585023    
Other Study ID Numbers: PRUA1GR-2013-00000220
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Abortion, Spontaneous
Fetal Death
Pregnancy Complications
Death
Pathologic Processes