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

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: Pregnancy Loss
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 200

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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.	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

• Sponsor: University Hospital of Ferrara

Study record dates

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: Pathologic Processes; Pregnancy Complications; Death; Abortion, Spontaneous; Fetal Death
• 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