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

June 30, 2018 updated by: Angela Graziano, University Hospital of Ferrara

Silent Intracellular Infections and Early Pregnancy Loss

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women who underwent revision of uterine cavity for spontaneous abortion or voluntary termination of pregnancy

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
December 2014 - April 2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Ferrara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 15, 2014

Primary Completion (ACTUAL)

November 15, 2016

Study Completion (ACTUAL)

May 14, 2017

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

June 30, 2018

First Posted (ACTUAL)

July 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 12, 2018

Last Update Submitted That Met QC Criteria

June 30, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRUA1GR-2013-00000220

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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