Infections and Pregnancy Loss: Correlation Between Abortion and Silent Infections.
Silent Intracellular Infections and Early Pregnancy Loss
1 other identifier
observational
200
0 countries
N/A
Brief Summary
Correlation between the presence of intracellular viruses/bacteria and the incidence of miscarriage during the first trimester of pregnancy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2014
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2017
CompletedFirst Submitted
Initial submission to the registry
June 4, 2018
CompletedFirst Posted
Study publicly available on registry
July 12, 2018
CompletedJuly 12, 2018
June 1, 2018
2 years
June 4, 2018
June 30, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Spontaneous miscarriage
The study group will be recruited at admission for uterine cavity revision planned for spontaneous abortion.
Voluntary pregnancy interruption
The control group will be recruited at admission for uterine cavity revision planned for voluntary pregnancy interruption.
Interventions
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.
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.
Eligibility Criteria
Women who underwent revision of uterine cavity for spontaneous abortion or voluntary termination of pregnancy
You may not qualify if:
- age of the patients range from 18 to 42 years old;
- gestational age ranging in the first 12 weeks.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
All samples, both spontaneous (spontaneous miscarriage) and elective (voluntary interruption of pregnancy), will be obtained after uterine cavity curettage. All women underwent PBMC extraction from peripheral whole blood.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
June 4, 2018
First Posted
July 12, 2018
Study Start
November 15, 2014
Primary Completion
November 15, 2016
Study Completion
May 14, 2017
Last Updated
July 12, 2018
Record last verified: 2018-06