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

Sponsor
University Hospital of Ferrara (Other)
Overall Status
Completed
CT.gov ID
NCT03585023
Collaborator
(none)
200
29.9

Study Details

Study Description

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 Phase
  • 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

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 :
Nov 15, 2014
Actual Primary Completion Date :
Nov 15, 2016
Actual Study Completion Date :
May 14, 2017

Arms and Interventions

Arm 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

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 42 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No

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

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital of Ferrara

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Angela Graziano, Doctor, University Hospital of Ferrara
ClinicalTrials.gov Identifier:
NCT03585023
Other Study ID Numbers:
  • PRUA1GR-2013-00000220
First Posted:
Jul 12, 2018
Last Update Posted:
Jul 12, 2018
Last Verified:
Jun 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2018