PregnancyCOroFetNCT04360811
Assessment of Obstetric, Fetal and Neonatal Risks and Vertical SARS-CoV-2 Transmission During COVID-19 Pandemic
A study testing COVID 19 diagnostic test by PCR in people with Pregnancy, run by University Hospital, Toulouse at 1 site in France.
Trial summary
A new coronavirus (COVID-19) highlighted at the end of 2019 in China is spreading across all continents. Most often at the origin of a mild infectious syndrome, associating benign symptoms (such as fever, cough, and headache) to different degrees, COVID-19 can cause serious pulmonary pathologies and sometimes death. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- COVID 19 diagnostic test by PCR
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,494 participants
- Where
- 1 siteFrance
- Study dates
- 17 Apr 2020to 31 Mar 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women over 18 years old on the date of inclusion
- Pregnant women coming to deliver in the Paule de Viguier maternity unit of Toulouse's University Hospital between April 2020 and April 2021 regardless the pregnancy outcomes (live births, IUFD, miscarriages, medical termination of pregnancy ) and the term
- Women affiliated to a social security system (including AME)
Who cannot join
- Voluntary termination of pregnancy
- Language barrier
- Patient under a legal protection measure (guardianship, curatorship, or safeguard of justice)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Obstetric, Fetal and Neonatal Risks and Vertical SARS-CoV-2 Transmission During COVID-19 Pandemic by Creation and Analysis of a Biological and Tissue Collection of Pregnancy Outcomes
A new coronavirus (COVID-19) highlighted at the end of 2019 in China is spreading across all continents. Most often at the origin of a mild infectious syndrome, associating benign symptoms (such as fever, cough, and headache) to different degrees, COVID-19 can cause serious pulmonary pathologies and sometimes death. Data on the consequences during pregnancy are limited. The first Chinese data published seem to show that the symptoms in pregnant women are the same as those of the general population. There are no cases of intrauterine maternal-fetal transmission, but cases of newborns infected early suggest that there could be vertical intrauterine, perpartum or neonatal transmission. Prematurity and cases of respiratory distress in newborns of infected mothers have been described. Subsequently, an in-depth analysis of cases in pregnant women and pregnancy issues are necessary in order to improve knowledge on the subject.
Read the detailed description
The main objective of this project is to set up a biological and tissue collection in order to study the transplacental passage of the SARS-CoV-2 virus, and the pregnancy outcomes (miscarriage, intra uterine fetal death, medical termination of pregnancy or living birth) during COVID-19 pandemic. The biological and tissue collection will be made up of systematic samples taken from parturient women and their pregnancy outcome at the time of their arrival at the maternity unit to deliver whatever their term and pregnancy outcome. This inclusion will concern all pregnant women, both symptomatic and asymptomatic positive COVID-19 women, and negative COVID-19 women. All women included will have a serological test to check their immunity status to SARS-CoV-2 in order to study pregnant women with an unnoticed COVID-19 infection during their pregnancy. The inclusion time will extend from the epidemic period until a year after, in order to document the outcomes of pregnant women potentially exposed to SARS-CoV-2 in early pregnancy. Samples analyses will be carried out after the epidemic peak to not overload laboratories in times of crisis.
The challenge is to have a better knowledge of the SARS-CoV-2 epidemiological and virological characteristics in particular its involvement in maternal-fetal morbidity and mortality, and to better understand the organs affected and the pathways of contamination within this particular mother-child duo.
- Conditions
- Pregnancy
- Being tested
- COVID 19 diagnostic test by PCR
- Keywords
- Pregnant women, pandemic, COVID-19, vertical mother-fetal transmission, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID 19 diagnostic test by PCRDiagnostic test
- Inclusion of patients with clinical data (in a eCRF) and various samples collection according to the outcome of pregnancy
- Storage and freezing samples for subsequent analysis by RT-PCR COVID-19 (maternal saliva, cord blood, fetal stools, placenta, fetal tissue, amniotic fluid according to pregnancy outcomes) and by maternal and newborn and / or fetal serologies testing
- Pathological study of placentas and fetal autopsies
- Histology of positive COVID-19 placentas
- Brain and visceral histology of positive COVID-19 fetuses autopsied
- Analysis of patient comorbidities and comparison in the different groups
- Final statistical analysis
| Study group | Role | What they receive |
|---|---|---|
| Unexposed group : COVID 19 negatif pregant woman | Other | COVID-19 negative women (not immunize Receives: Diagnostic Test: COVID 19 diagnostic test by PCR |
| Exposed group : COVID 19 positif pregant woman | Other | Women positive for COVID-19 (symptomatic and asymptomatic) COVID-19 negative women with long-standing immunity Receives: Diagnostic Test: COVID 19 diagnostic test by PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of positive COVID-19 women
Exposure to SARS-CoV-2 will be measured the day of delivery by RT-PCR on maternal saliva and by serology on maternal blood
Measured: Day 0
Secondary outcomes (1)
number of positive COVID-19 women
Description of the number of positive COVID-19 RT-PCRs in the conception products: amniotic fluid, frozen placenta fragment, frozen fetal tissue, cord blood or frozen cord fragment
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start17 Apr 2020
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,494 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte Dubucs, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360811
- Sponsor's protocol ID
- RC31/20/0123
- Acronym
- COroFet
- Status last verified
- Jul 2022
- First submitted
- 22 Apr 2020
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Obstetric, Fetal and Neonatal Risks and Vertical SARS-CoV-2 Transmission During COVID-19 Pandemic by Creation and Analysis of a Biological and Tissue Collection of Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT04360811
- Acronym / sponsor ID
- COroFet / RC31/20/0123
- Conditions
- Pregnancy
- Keywords
- Pregnant women, pandemic, COVID-19, vertical mother-fetal transmission, SARS-CoV-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,494 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 17 Apr 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 24 Apr 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.
A new coronavirus (COVID-19) highlighted at the end of 2019 in China is spreading across all continents. Most often at the origin of a mild infectious syndrome, associating benign symptoms (such as fever, cough, and headache) to different degrees, COVID-19 can cause serious pulmonary pathologies and sometimes death. Data on the consequences during pregnancy are limited. The first Chinese data published seem to show that the symptoms in pregnant women are the same as those of the general population. There are no cases of intrauterine maternal-fetal transmission, but cases of newborns infected early suggest that there could be vertical intrauterine, perpartum or neonatal transmission. Prematurity and cases of respiratory distress in newborns of infected mothers have been described. Subsequently, an in-depth analysis of cases in pregnant women and pregnancy issues are necessary in order to improve knowledge on the subject.
Detailed description
The main objective of this project is to set up a biological and tissue collection in order to study the transplacental passage of the SARS-CoV-2 virus, and the pregnancy outcomes (miscarriage, intra uterine fetal death, medical termination of pregnancy or living birth) during COVID-19 pandemic. The biological and tissue collection will be made up of systematic samples taken from parturient women and their pregnancy outcome at the time of their arrival at the maternity unit to deliver whatever their term and pregnancy outcome. This inclusion will concern all pregnant women, both symptomatic and asymptomatic positive COVID-19 women, and negative COVID-19 women. All women included will have a serological test to check their immunity status to SARS-CoV-2 in order to study pregnant women with an unnoticed COVID-19 infection during their pregnancy. The inclusion time will extend from the epidemic period until a year after, in order to document the outcomes of pregnant women potentially exposed to SARS-CoV-2 in early pregnancy. Samples analyses will be carried out after the epidemic peak to not overload laboratories in times of crisis.
The challenge is to have a better knowledge of the SARS-CoV-2 epidemiological and virological characteristics in particular its involvement in maternal-fetal morbidity and mortality, and to better understand the organs affected and the pathways of contamination within this particular mother-child duo.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unexposed group : COVID 19 negatif pregant woman | Other | Diagnostic Test: COVID 19 diagnostic test by PCRCOVID-19 negative women (not immunize |
| Exposed group : COVID 19 positif pregant woman | Other | Diagnostic Test: COVID 19 diagnostic test by PCRWomen positive for COVID-19 (symptomatic and asymptomatic) COVID-19 negative women with long-standing immunity |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women over 18 years old on the date of inclusion
- Pregnant women coming to deliver in the Paule de Viguier maternity unit of Toulouse's University Hospital between April 2020 and April 2021 regardless the pregnancy outcomes (live births, IUFD, miscarriages, medical termination of pregnancy ) and the term
- Women affiliated to a social security system (including AME)
Key exclusion criteria (3 listed)
- Voluntary termination of pregnancy
- Language barrier
- Patient under a legal protection measure (guardianship, curatorship, or safeguard of justice)
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 |
|---|---|---|
| COVID 19 diagnostic test by PCR1. Inclusion of patients with clinical data (in a eCRF) and various samples collection according to the outcome of pregnancy 2. Storage and freezing samples for subsequent analysis by RT-PCR COVID-19 (maternal saliva, cord blood, fetal stools, placenta, fetal tissue, amniotic fluid according to pregnancy outcomes) and by maternal and newborn and / or fetal serologies testing 3. Pathological study of placentas and fetal autopsies * Histology of positive COVID-19 placentas * Brain and visceral histology of positive COVID-19 fetuses autopsied 4. Analysis of patient comorbidities and comparison in the different groups 5. Final statistical analysis | Diagnostic test | Exposed group : COVID 19 positif pregant woman, Unexposed group : COVID 19 negatif pregant woman |
Primary outcome
number of positive COVID-19 women
Time frame: Day 0
Exposure to SARS-CoV-2 will be measured the day of delivery by RT-PCR on maternal saliva and by serology on maternal blood
1 secondary outcome
number of positive COVID-19 women
Time frame: Day 0
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 19 Jul 2022.
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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.
Charlotte Dubucs, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID 19 diagnostic test by PCR in people with Pregnancy, run by University Hospital, Toulouse 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 3 inclusion and 3 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 19 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?
number of positive COVID-19 women (time frame: Day 0). 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 19 Jul 2022.