Identification of the Mother or Fetus Contamination by SARS Cov-2NCT04387253
Study of Late Fetal Loss in Poitou-Charentes. GYNE-COVID
A study testing Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus in people with Identification of the Mother or Fetus Contamination by SARS Cov-2 and Research the Presence of Viruses at Different Sites of the Mother and the Fetus or Father, run by Poitiers University Hospital at 1 site in France.
Trial summary
Maternal-fetal transmission in the second or third trimester of pregnancy of the SARS-COV-2 virus could explain some late fetal losses. Finding a cause in the context of fetal loss is essential for parents and caregivers. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Identification of the Mother or Fetus Contamination by SARS Cov-2, Research the Presence of Viruses at Different Sites of the Mother and the Fetus or Father, The Survey Builds on a Network Work Already Organized Around the CPDPN of Poitou-Charentes
- What is being tested?
- Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2020to 17 Jun 2022
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Major patient
- Patient with late spontaneous abortion (≥15 weeks of gestation)
- Benefiting from a Social Security scheme
- Patient who consented to participate in the study
- Free subject, without tutorship, curatorship or subordination
Who cannot join
- Persons not benefiting from a Social Security scheme or not benefiting from it through a third party.
- Concurrent participation in another clinical research study.
Trial locations and contacts
1 site in 1 country.
About this study
Maternal-fetal transmission in the second or third trimester of pregnancy of the SARS-COV-2 virus could explain some late fetal losses.
Finding a cause in the context of fetal loss is essential for parents and caregivers. It helps to understand the history of the disease, to address the possible risk of a recurrence and to plan for future pregnancies.
Read more
If the maternal-fetal transmission of COVID 19 is confirmed and that it is responsible for obstetric complications, a preventive action could be proposed to the patients by the preconception vaccination.
The investigators are seeking to clarify the frequency of this transmission is information awaited by caregivers, women, couples in particular when the latter are in distress from late fetal loss.
- Conditions
- Identification of the Mother or Fetus Contamination by SARS Cov-2, Research the Presence of Viruses at Different Sites of the Mother and the Fetus or Father, The Survey Builds on a Network Work Already Organized Around the CPDPN of Poitou-Charentes, Analysis Laboratories of the Poitiers CHU
- Being tested
- Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification by PCR of the SARS-COV-2 virus in samples taken from the fetusDiagnostic test
Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus Presence of SARS-COV-2 virus in samples taken from mother and father. Circulating anti-SARS-COV-2 antibodies in the mother.
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the prevalence of SARS-CoV-2 infection in women with late fetal loss of unexplained cause.
Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start23 May 2020
- Primary completion17 Jun 2022
- Study completion17 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Identification of the Mother or Fetus Contamination by SARS Cov-2Studies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387253
- Sponsor's protocol ID
- GYNE-COVID
- Status last verified
- Jul 2022
- First submitted
- 12 May 2020
- Last updated
- 12 Jul 2022
- 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 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Late Fetal Loss in Poitou-Charentes. GYNE-COVID
- ClinicalTrials.gov ID
- NCT04387253
- Acronym / sponsor ID
- GYNE-COVID
- Conditions
- Identification of the Mother or Fetus Contamination by SARS Cov-2, Research the Presence of Viruses at Different Sites of the Mother and the Fetus or Father, The Survey Builds on a Network Work Already Organized Around the CPDPN of Poitou-Charentes, Analysis Laboratories of the Poitiers CHU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 23 May 2020 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 13 May 2020 (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.
Maternal-fetal transmission in the second or third trimester of pregnancy of the SARS-COV-2 virus could explain some late fetal losses.
Finding a cause in the context of fetal loss is essential for parents and caregivers. It helps to understand the history of the disease, to address the possible risk of a recurrence and to plan for future pregnancies.
If the maternal-fetal transmission of COVID 19 is confirmed and that it is responsible for obstetric complications, a preventive action could be proposed to the patients by the preconception vaccination.
The investigators are seeking to clarify the frequency of this transmission is information awaited by caregivers, women, couples in particular when the latter are in distress from late fetal loss.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Major patient
- Patient with late spontaneous abortion (≥15 weeks of gestation)
- Benefiting from a Social Security scheme
- Patient who consented to participate in the study
- Free subject, without tutorship, curatorship or subordination
Key exclusion criteria (2 listed)
- Persons not benefiting from a Social Security scheme or not benefiting from it through a third party.
- Concurrent participation in another clinical research study.
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 |
|---|---|---|
| Identification by PCR of the SARS-COV-2 virus in samples taken from the fetusIdentification by PCR of the SARS-COV-2 virus in samples taken from the fetus Presence of SARS-COV-2 virus in samples taken from mother and father. Circulating anti-SARS-COV-2 antibodies in the mother. | Diagnostic test | – |
Primary outcome
Estimate the prevalence of SARS-CoV-2 infection in women with late fetal loss of unexplained cause.
Time frame: 2 months
Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus
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 2022.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus in people with Identification of the Mother or Fetus Contamination by SARS Cov-2 and Research the Presence of Viruses at Different Sites of the Mother and the Fetus or Father, run by Poitiers University Hospital at 1 site in France.
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 5 inclusion and 2 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 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Estimate the prevalence of SARS-CoV-2 infection in women with late fetal loss of unexplained cause. (time frame: 2 months). 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 2022.