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

Pregnancy Loss Clinical Trial

Official title:

Silent Intracellular Infections and Early Pregnancy Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03585023
• Other study ID #: PRUA1GR-2013-00000220
• Status: Completed
• Start date: November 15, 2014
• Est. completion date: May 14, 2017

Study information

• Verified date: June 2018
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 14, 2017
• Est. primary completion date: November 15, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Fetal Death
• Infection
• Pregnancy Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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