Pregnancy LossNCT03585023
Infections and Pregnancy Loss: Correlation Between Abortion and Silent Infections.
An observational study of Pregnancy Loss, run by University Hospital of Ferrara.
Trial summary
Correlation between the presence of intracellular viruses/bacteria and the incidence of miscarriage during the first trimester of pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Pregnancy Loss
- What is being tested?
- Spontaneous miscarriage and Voluntary pregnancy interruption
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2014to 14 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Study population: Women who underwent revision of uterine cavity for spontaneous abortion or voluntary termination of pregnancy
Who may be able to join
- age of the patients range from 18 to 42 years old;
- gestational age ranging in the first 12 weeks.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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
- Conditions
- Pregnancy Loss
- Being tested
- Spontaneous miscarriage, Voluntary pregnancy interruption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spontaneous miscarriageDiagnostic 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 interruptionDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous miscarriage | The study group will be recruited at admission for uterine cavity revision planned for spontaneous abortion. Receives: Diagnostic Test: Spontaneous miscarriage; Diagnostic Test: Voluntary pregnancy interruption | |
| Voluntary pregnancy interruption | The control group will be recruited at admission for uterine cavity revision planned for voluntary pregnancy interruption. Receives: Diagnostic Test: Spontaneous miscarriage; Diagnostic Test: Voluntary pregnancy interruption |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: December 2014 - April 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start15 Nov 2014
- Primary completion15 Nov 2016
- Study completion14 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Graziano, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585023
- Sponsor's protocol ID
- PRUA1GR-2013-00000220
- Status last verified
- Jun 2018
- First submitted
- 4 Jun 2018
- Last updated
- 12 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silent Intracellular Infections and Early Pregnancy Loss
- ClinicalTrials.gov ID
- NCT03585023
- Acronym / sponsor ID
- PRUA1GR-2013-00000220
- Conditions
- Pregnancy Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 15 Nov 2014 (actual)
- Primary completion
- 15 Nov 2016 (actual)
- Study completion
- 14 May 2017 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Correlation between the presence of intracellular viruses/bacteria and the incidence of miscarriage during the first trimester of pregnancy.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spontaneous miscarriage | – | Diagnostic Test: Spontaneous miscarriage, Diagnostic Test: Voluntary pregnancy interruptionThe study group will be recruited at admission for uterine cavity revision planned for spontaneous abortion. |
| Voluntary pregnancy interruption | – | Diagnostic Test: Spontaneous miscarriage, Diagnostic Test: Voluntary pregnancy interruptionThe control group will be recruited at admission for uterine cavity revision planned for voluntary pregnancy interruption. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who underwent revision of uterine cavity for spontaneous abortion or voluntary termination of pregnancy
Key inclusion criteria (2 listed)
- age of the patients range from 18 to 42 years old;
- gestational age ranging in the first 12 weeks.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spontaneous miscarriageViral 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 | Spontaneous miscarriage, Voluntary pregnancy interruption |
| Voluntary pregnancy interruptionViral 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 | Spontaneous miscarriage, Voluntary pregnancy interruption |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Loss, run by University Hospital of Ferrara.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individuation of DNA of intracellular agents (viral und bacterial) in chorionic tissue und blood sample. (time frame: December 2014 - April 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018; AzTrials last refreshed its copy on 7 Nov 2026.