PregnancyCOVIPREGNCT04355234
Prevalence and Impact of COVID-19 Infection in Pregnant Women, Fetuses and Newborns
A study testing identify SARS-CoV-2 infection by serology and collection of biological samples in people with Pregnancy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
A novel human coronavirus, named SevereAcute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), emerged in China, in late 2019, and is now spreading quickly causing a pandemic. It is usually responsible for a mild infectious syndrome, but patients can also develop pneumonia, acute respiratory failure and other serious… 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?
- identify SARS-CoV-2 infection by serology and collection of biological samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,446 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2020to 31 Aug 2021
- 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
- Any pregnant woman giving birth or having a miscarriage after 15 weeks.
- Major patient
Who cannot join
- Patients not speaking French and not accompanied by a translator
- Patients under curatorship / guardianship
- Refusal to participate in research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Impact of SARS-COV-2 Infection in Pregnant Women, Fetuses and Newborns
A novel human coronavirus, named SevereAcute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), emerged in China, in late 2019, and is now spreading quickly causing a pandemic. It is usually responsible for a mild infectious syndrome, but patients can also develop pneumonia, acute respiratory failure and other serious complications. To date, very little and controversial literature is available on the impact of SARS-CoV-2 infection on pregnancy, and the potential risk of vertical transmission.
Therefore, the first part of the study, will evaluate the proportion of pregnant woman infected by SARS-CoV-2 during pregnancy over the next six months by performing SARS-CoV-2 serology during pregnancy and at delivery . This information will be correlated to pregnancy and neonatal outcome. The second part of the study 2 will collect sera from several mandatory screening that are kept for one year. Those will be used for assessing the time of the seroconversion and variations of susceptibility to infection with gestational age as well as the impact of social distancing measures.
Read more
Concerning neonates born to mothers with documented SARS-CoV-2 infection during pregnancy, only few cases of congenital infections were recently reported because of pneumonia related to SARS-CoV-2 infection and/or positive IgM at birth.
It remains unclear whether neonatal infection can follow transplacental transmission of SARS-CoV-2 during pregnancy and/or through early per- and postnatal exposure, including breast-feeding. In order to investigate these hypotheses, the third part of the study will perform, SARS-CoV-2 PCR tests in a variety of samples collected from infected-mother (symptomatic during the pregnancy and PCR confirmed) and child pairs, at delivery and in the postpartum period.
Read the detailed description
A novel human coronavirus, named SevereAcute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), emerged in China, in late 2019, and is now spreading quickly causing a pandemic. It is usually responsible for a mild infectious syndrome, but patients can also develop pneumonia, acute respiratory failure and other serious complications. To date, very little and controversial literature is available on the impact of SARS-CoV-2 infection on pregnancy, and the potential risk of vertical transmission. Currently we do not know how many pregnant women may be infected by SARS-CoV-2 and if, as for influenza, they might more likely develop severe infection.
Therefore, the first part of the study, will evaluate the proportion of pregnant woman infected by SARS-CoV-2 during pregnancy over the next six months by performing SARS-CoV-2 serology during pregnancy and at delivery. This information will be correlated to pregnancy and neonatal outcome. The second part of the study 2 will collect sera from several mandatory screening that are kept for one year. Those will be used for assessing the time of the seroconversion and variations of susceptibility to infection with gestational age as well as the impact of social distancing measures.
Concerning neonates born to mothers with documented SARS-CoV-2 infection during pregnancy, only few cases of congenital infections were recently reported because of pneumonia related to SARS-CoV-2 infection and/or positive IgM at birth.
It remains unclear whether neonatal infection can follow transplacental transmission of SARS-CoV-2 during pregnancy and/or through early per- and postnatal exposure, including breast-feeding. In order to investigate these hypotheses, the third part of the study will perform, SARS-CoV-2 PCR tests in a variety of samples collected from infected-mother (symptomatic during the pregnancy and PCR confirmed) and child pairs, at delivery and in the postpartum period.
- Conditions
- Pregnancy
- Being tested
- identify SARS-CoV-2 infection by serology, collection of biological samples
- Keywords
- pregnancy; SARS-CoV-2; COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
identify SARS-CoV-2 infection by serologyDiagnostic test
Blood samples at delivery to identify SARS-CoV-2 infection by serology
collection of biological samplesBiological
Creation of a specific collection of biological samples for new investigations thanks to the collection of several biological samples at the time of maternal SARS-CoV-2 infection, at delivery and in the postpartum period in the parturient and her newborn.
| Study group | Role | What they receive |
|---|---|---|
| all patients | Experimental | Not described Receives: Diagnostic Test: identify SARS-CoV-2 infection by serology |
| patients who presented a SARS-CoV-2 infection confirmed by PCR | Experimental | Not described Receives: Biological: collection of biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprevalence or Number of women who are positive for SARS-CoV-2 in parturient woman
Number of women who are positive for SARS-CoV-2
Measured: at delivery
Secondary outcomes (9)
Consequences of SARS-CoV-2 infection in pregnant women and their newborns : Pregnancy outcome, maternal or neonatal complications
Correlation between exposure to the virus (confirmed by serology) and its impact on pregnancy and its outcome : Pregnancy outcome, maternal or neonatal complications
Measured: 2 months after delivery
Assessment of the vertical transmission of SARS-CoV-2 and the possible routes of this transmission in women who are positive for SARS-CoV-2 during pregnancy
Presence of virus (objectified by PCR) in the different biological compartments tested :In the mother: vaginal, anal, amniotic fluid and in the newborn: nasopharyngeal swabs, gastric aspiration, anal swab.
Measured: at delivery
Assessment of the vertical transmission of SARS-CoV-2 and the possible routes of this transmission in women who are positive for SARS-CoV-2 during pregnancy
Presence of virus (objectified by PCR) in the different biological compartments tested :In the mother: milk and stool samples and in the newborn: nasopharyngeal swabs, urine and stool.
Measured: 5 days after delivery
Assessment of susceptibility to infection during the 3 trimesters of pregnancy
Evaluation of gestational age at SARSCoV-2 infection by performing serology on monthly collected serum samples (samples collected for routine management of pregnancy).
Measured: 5 days after delivery
Evaluation of the confinement on the risk of exposure to the virus during pregnancy .
Study of the methods of confinement by investigation
Measured: 5 days after delivery
collection of biological samples for new investigations in women who are positive for SARS-CoV-2 during pregnancy.
A biobank will be carried out, including the collection of several biological samples at the time of maternal SARS-CoV-2 infection, at delivery and in the postpartum period in the parturient and her newborn
Measured: 5 days after delivery
Assessment of the rate of SARS-CoV-2 infection in pregnant women the risk factors for the disease.
Risk factors in uninfected women
Measured: at delivery
Assessment of the rate of SARS-CoV-2 infection in pregnant women the risk factors for the disease.
Risk factors in infected and symptomatic women.
Measured: at delivery
Assessment of the rate of SARS-CoV-2 infection in newborns and the risk factors for the disease.
risk factors in newborns
Measured: at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start4 May 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, open study with inclusions of 2200 parturients. All parturients divided into 2 groups: * 2200 patients whose SARS-Cov-2 status is unknown during pregnancy * 300 patients who presented a SARS-CoV-2 infection confirmed by PCR during pregnancy whatever the term
- Masking
- None (open label)
- Enrolment
- 2,446 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christelle Vauloup Fellous, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355234
- Sponsor's protocol ID
- APHP 200448
- Acronym
- COVIPREG
- Status last verified
- Apr 2020
- First submitted
- 17 Apr 2020
- Last updated
- 22 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vivanti AJ, Couffignal C, Sibiude J, Cordier AG, Tsatsaris V, Rozenberg F, Launay O, Benachi A, De Luca D, Ancel PY, Marcault E, Ville Y, Carrara J, Luton D, Dommergues M, Borie C, Kayem G, Lecomte L, Leruez-Ville M, Perillaud-Dubois C, Biran V, Manchon P, Picone O, Vauloup-Fellous C. Maternal and neonatal outcomes of French prospective multicenter cohort study COVIPREG during the first two COVID-19 waves. J Gynecol Obstet Hum Reprod. 2024 Jun;53(6):102764. doi: 10.1016/j.jogoh.2024.102764. Epub 2024 Mar 16.
PubMed 38492667Brebant D, Couffignal C, Manchon P, Duquesne S, Picone O, Vauloup-Fellous C. Transplacental transfer of anti-SARS-CoV-2 neutralizing antibodies in comparison to other pathogens total antibodies. J Clin Virol. 2023 Aug;165:105495. doi: 10.1016/j.jcv.2023.105495. Epub 2023 May 26.
PubMed 37295035
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Impact of SARS-COV-2 Infection in Pregnant Women, Fetuses and Newborns
- ClinicalTrials.gov ID
- NCT04355234
- Acronym / sponsor ID
- COVIPREG / APHP 200448
- Conditions
- Pregnancy
- Keywords
- pregnancy; SARS-CoV-2; COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,446 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 May 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 21 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 novel human coronavirus, named SevereAcute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), emerged in China, in late 2019, and is now spreading quickly causing a pandemic. It is usually responsible for a mild infectious syndrome, but patients can also develop pneumonia, acute respiratory failure and other serious complications. To date, very little and controversial literature is available on the impact of SARS-CoV-2 infection on pregnancy, and the potential risk of vertical transmission.
Therefore, the first part of the study, will evaluate the proportion of pregnant woman infected by SARS-CoV-2 during pregnancy over the next six months by performing SARS-CoV-2 serology during pregnancy and at delivery . This information will be correlated to pregnancy and neonatal outcome. The second part of the study 2 will collect sera from several mandatory screening that are kept for one year. Those will be used for assessing the time of the seroconversion and variations of susceptibility to infection with gestational age as well as the impact of social distancing measures.
Concerning neonates born to mothers with documented SARS-CoV-2 infection during pregnancy, only few cases of congenital infections were recently reported because of pneumonia related to SARS-CoV-2 infection and/or positive IgM at birth.
It remains unclear whether neonatal infection can follow transplacental transmission of SARS-CoV-2 during pregnancy and/or through early per- and postnatal exposure, including breast-feeding. In order to investigate these hypotheses, the third part of the study will perform, SARS-CoV-2 PCR tests in a variety of samples collected from infected-mother (symptomatic during the pregnancy and PCR confirmed) and child pairs, at delivery and in the postpartum period.
Detailed description
A novel human coronavirus, named SevereAcute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), emerged in China, in late 2019, and is now spreading quickly causing a pandemic. It is usually responsible for a mild infectious syndrome, but patients can also develop pneumonia, acute respiratory failure and other serious complications. To date, very little and controversial literature is available on the impact of SARS-CoV-2 infection on pregnancy, and the potential risk of vertical transmission. Currently we do not know how many pregnant women may be infected by SARS-CoV-2 and if, as for influenza, they might more likely develop severe infection.
Therefore, the first part of the study, will evaluate the proportion of pregnant woman infected by SARS-CoV-2 during pregnancy over the next six months by performing SARS-CoV-2 serology during pregnancy and at delivery. This information will be correlated to pregnancy and neonatal outcome. The second part of the study 2 will collect sera from several mandatory screening that are kept for one year. Those will be used for assessing the time of the seroconversion and variations of susceptibility to infection with gestational age as well as the impact of social distancing measures.
Concerning neonates born to mothers with documented SARS-CoV-2 infection during pregnancy, only few cases of congenital infections were recently reported because of pneumonia related to SARS-CoV-2 infection and/or positive IgM at birth.
It remains unclear whether neonatal infection can follow transplacental transmission of SARS-CoV-2 during pregnancy and/or through early per- and postnatal exposure, including breast-feeding. In order to investigate these hypotheses, the third part of the study will perform, SARS-CoV-2 PCR tests in a variety of samples collected from infected-mother (symptomatic during the pregnancy and PCR confirmed) and child pairs, at delivery and in the postpartum period.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicenter, open study with inclusions of 2200 parturients. All parturients divided into 2 groups: * 2200 patients whose SARS-Cov-2 status is unknown during pregnancy * 300 patients who presented a SARS-CoV-2 infection confirmed by PCR during pregnancy whatever the term
| Arm | Type | Receives |
|---|---|---|
| all patients | Experimental | Diagnostic Test: identify SARS-CoV-2 infection by serology |
| patients who presented a SARS-CoV-2 infection confirmed by PCR | Experimental | Biological: collection of biological samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any pregnant woman giving birth or having a miscarriage after 15 weeks.
- Major patient
Key exclusion criteria (3 listed)
- Patients not speaking French and not accompanied by a translator
- Patients under curatorship / guardianship
- Refusal to participate in research
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 |
|---|---|---|
| identify SARS-CoV-2 infection by serologyBlood samples at delivery to identify SARS-CoV-2 infection by serology | Diagnostic test | all patients |
| collection of biological samplesCreation of a specific collection of biological samples for new investigations thanks to the collection of several biological samples at the time of maternal SARS-CoV-2 infection, at delivery and in the postpartum period in the parturient and her newborn. | Biological | patients who presented a SARS-CoV-2 infection confirmed by PCR |
Primary outcome
Seroprevalence or Number of women who are positive for SARS-CoV-2 in parturient woman
Time frame: at delivery
Number of women who are positive for SARS-CoV-2
9 secondary outcomes
Consequences of SARS-CoV-2 infection in pregnant women and their newborns : Pregnancy outcome, maternal or neonatal complications
Time frame: 2 months after delivery
Assessment of the vertical transmission of SARS-CoV-2 and the possible routes of this transmission in women who are positive for SARS-CoV-2 during pregnancy
Time frame: at delivery
Assessment of the vertical transmission of SARS-CoV-2 and the possible routes of this transmission in women who are positive for SARS-CoV-2 during pregnancy
Time frame: 5 days after delivery
Assessment of susceptibility to infection during the 3 trimesters of pregnancy
Time frame: 5 days after delivery
Evaluation of the confinement on the risk of exposure to the virus during pregnancy .
Time frame: 5 days after delivery
collection of biological samples for new investigations in women who are positive for SARS-CoV-2 during pregnancy.
Time frame: 5 days after delivery
Assessment of the rate of SARS-CoV-2 infection in pregnant women the risk factors for the disease.
Time frame: at delivery
Assessment of the rate of SARS-CoV-2 infection in pregnant women the risk factors for the disease.
Time frame: at delivery
Assessment of the rate of SARS-CoV-2 infection in newborns and the risk factors for the disease.
Time frame: at delivery
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 22 Jun 2022.
- Derived from this study: PubMed 38492667Vivanti AJ, Couffignal C, Sibiude J, Cordier AG, Tsatsaris V, Rozenberg F, Launay O, Benachi A, De Luca D, Ancel PY, Marcault E, Ville Y, Carrara J, Luton D, Dommergues M, Borie C, Kayem G, Lecomte L, Leruez-Ville M, Perillaud-Dubois C, Biran V, Manchon P, Picone O, Vauloup-Fellous C. Maternal and neonatal outcomes of French prospective multicenter cohort study COVIPREG during the first two COVID-19 waves. J Gynecol Obstet Hum Reprod. 2024 Jun;53(6):102764. doi: 10.1016/j.jogoh.2024.102764. Epub 2024 Mar 16.
- Derived from this study: PubMed 37295035Brebant D, Couffignal C, Manchon P, Duquesne S, Picone O, Vauloup-Fellous C. Transplacental transfer of anti-SARS-CoV-2 neutralizing antibodies in comparison to other pathogens total antibodies. J Clin Virol. 2023 Aug;165:105495. doi: 10.1016/j.jcv.2023.105495. Epub 2023 May 26.
- Individual participant dataSharing planned: Undecided
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
Christelle Vauloup Fellous principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing identify SARS-CoV-2 infection by serology and collection of biological samples in people with Pregnancy, run by Assistance Publique - Hôpitaux de Paris 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 2 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 22 Jun 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?
Seroprevalence or Number of women who are positive for SARS-CoV-2 in parturient woman (time frame: at delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04355234, which also lists 2 linked publications.
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 22 Jun 2022.