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

NCT ID: NCT03585023

Last Updated: 2018-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-15

Study Completion Date

2017-05-14

Brief Summary

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

Detailed Description

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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

Conditions

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Pregnancy Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Spontaneous miscarriage

The study group will be recruited at admission for uterine cavity revision planned for spontaneous abortion.

Spontaneous miscarriage

Intervention Type 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

Intervention Type 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

The control group will be recruited at admission for uterine cavity revision planned for voluntary pregnancy interruption.

Spontaneous miscarriage

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of Ferrara

OTHER

Sponsor Role lead

Responsible Party

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Angela Graziano

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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PRUA1GR-2013-00000220

Identifier Type: -

Identifier Source: org_study_id

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