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Clinical Trials/NCT03585023
NCT03585023CompletedNot Applicable

Silent Intracellular Infections and Early Pregnancy Loss

University Hospital of Ferrara0 sites200 target enrollmentStarted: November 15, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
200
Primary Endpoint
Individuation of DNA of intracellular agents (viral und bacterial) in chorionic tissue und blood sample.

Study Overview

Brief Summary

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

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
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 42 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital of Ferrara
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Angela Graziano

Doctor

University Hospital of Ferrara

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