Covid19MaterCovNCT04726111
COVID-19 and Pregnancy: Placental and Immunological Impacts
A study testing Specimens specific for the study in people with Covid19, run by Hopital Foch at 1 site in France.
Trial summary
The aim of this study is to compare placental pathologies in patients with COVID 19 infection at the time of childbirth or a history of COVID 19 during pregnancy versus control patients Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Covid19
- What is being tested?
- Specimens specific for the study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 30 Dec 2020to 8 Sep 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
- Patient pregnant for more than 20 weeks with amenorrhea
- Having completed a COVID 19 PCR within 72 hours
- Admitted to the birthing room at Foch hospital for her delivery
Who cannot join
- Minor (age <18 years, on inclusion)
- Diabetes with and without insulin (only for the control group)
- High blood pressure (only for the control group),
- Preeclampsia (only for the control group)
- Infection during pregnancy: HIV, toxoplasmosis, rubella, CMV, syphilis.
- PCR Influenza A or B positive, proven by nasopharyngeal swab in the week preceding childbirth
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare placental pathologies in patients with COVID 19 infection at the time of childbirth or a history of COVID 19 during pregnancy versus control patients
Read the detailed description
The second wave of COVID 19 is currently sweeping through Europe. If the first wave brought reassuring elements on the risk of maternal-fetal transmission, it nevertheless counted an increase in severe maternal forms in the third trimester associated with more premature deliveries and cesarean sections. In addition, due to the very recent nature of this new infection, we have little data on the effect of SARS-COV 2 contracted during pregnancy on the fetus and on maternal-fetal exchanges.
Publications report an increase in growth retardation, maternal coagulopathies, preeclampsia and placental thrombosis. The vascular placental abnormalities observed in the first series must be confirmed and refined. Finally, pregnancy is marked by immunomodulation which can interfere with immune reactions. A better understanding of the immunological mechanisms in the mother and of the immunity transmitted to the fetus is necessary to better understand the maternal-fetal issues of COVID 19.
This prospective study concerns patients presenting for their delivery at Foch Hospital.
4 groups of patients will be identified in the delivery room after childbirth based on their COVID 19 PCR taken within 72 hours, their COVID 19 serology, or a history of positive COVID 19 PCR during pregnancy : 1 control group of 50 patients, 1 group of 50 asymptomatic patients, 1 group of 50 patients with symptoms, and 1 group of 50 cured patients who contracted the disease during pregnancy. The patients will have various samples: blood, umbilical cord blood, umbilical cord, placenta
- Conditions
- Covid19
- Being tested
- Specimens specific for the study
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specimens specific for the studyOther
Specimens (blood, umbilical cord, umbilical cord blood, placenta)
| Study group | Role | What they receive |
|---|---|---|
| Control patients | Other | Control patients (negative serology and PCR) Receives: Other: Specimens specific for the study |
| asymptomatic patients | Other | asymptomatic patients (PCR positive) Receives: Other: Specimens specific for the study |
| symptomatic patients | Other | symptomatic patients (PCR positive) Receives: Other: Specimens specific for the study |
| Cured patients | Other | cured patients who contracted the disease during pregnancy (positive serology in the 15 days preceding childbirth or history of positive PCR during pregnancy and negative PCR within 72 hours) Receives: Other: Specimens specific for the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placental histological evaluation
vascular hypoperfusion on the fetal and maternal side, thrombosis and other abnormalities
Measured: Delivery Day 0-Day1
Secondary outcomes (6)
Cellular analysis on maternal blood and cord blood: phenotyping from PBMCs and NFS with the characterization of lymphocyte populations by the CytodiffTM technique
Measured: Delivery Day 0 - Day 1
Cellular analysis on maternal blood and cord blood: functional activities from PBMCs and NFS with the characterization of lymphocyte populations by the CytodiffTM technique
Measured: Delivery Day 0 - Day 1
Number of cytokines in maternal blood and cord blood
Measured: Delivery Day 0 - Day 1
Number of immunoglobulins in maternal and fetal blood
Measured: Delivery Day 0 - Day 1
Maternal clinical evaluation then neonatal on medical file and telephone questionnaire 1 month after childbirth. Comparison of results between groups.
Maternal clinical evaluation (preeclampsia, retroplacental hematoma, severe symptoms of the disease, cesarean section for respiratory distress, hemorrhage during delivery, length of hospitalization, re-hospitalization within 30 days, sequelae) and fetal then neonatal (fetal death in utero , intrauterine growth retardation, premature delivery, birth weight, pH, cord lactates, APGAR score, neonatal hospitalization, intensive care hospitalization, length of hospitalization, notion of COVID 19 infection in the month that following childbirth) based on medical records and telephone questionnaire 1 month after childbirth. Comparison of results between groups.
Measured: 1 month postpartum Day 30
Foetal clinical evaluation then neonatal on medical file and telephone questionnaire 1 month after childbirth. Comparison of results between groups.
Maternal clinical evaluation (preeclampsia, retroplacental hematoma, severe symptoms of the disease, cesarean section for respiratory distress, hemorrhage during delivery, length of hospitalization, re-hospitalization within 30 days, sequelae) and fetal then neonatal (fetal death in utero , intrauterine growth retardation, premature delivery, birth weight, pH, cord lactates, APGAR score, neonatal hospitalization, intensive care hospitalization, length of hospitalization, notion of COVID 19 infection in the month that following childbirth) based on medical records and telephone questionnaire 1 month after childbirth. Comparison of results between groups.
Measured: 1 month postpartum Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start30 Dec 2020
- Primary completion30 Jul 2021
- Study completion8 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726111
- Sponsor's protocol ID
- 2020_0170
- Acronym
- MaterCov
- Status last verified
- Jun 2024
- First submitted
- 21 Jan 2021
- Last updated
- 7 Jun 2024
- 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 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 and Pregnancy: Placental and Immunological Impacts
- ClinicalTrials.gov ID
- NCT04726111
- Acronym / sponsor ID
- MaterCov / 2020_0170
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 8 Sep 2021 (actual)
- First posted
- 27 Jan 2021 (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.
The aim of this study is to compare placental pathologies in patients with COVID 19 infection at the time of childbirth or a history of COVID 19 during pregnancy versus control patients
Detailed description
The second wave of COVID 19 is currently sweeping through Europe. If the first wave brought reassuring elements on the risk of maternal-fetal transmission, it nevertheless counted an increase in severe maternal forms in the third trimester associated with more premature deliveries and cesarean sections. In addition, due to the very recent nature of this new infection, we have little data on the effect of SARS-COV 2 contracted during pregnancy on the fetus and on maternal-fetal exchanges.
Publications report an increase in growth retardation, maternal coagulopathies, preeclampsia and placental thrombosis. The vascular placental abnormalities observed in the first series must be confirmed and refined. Finally, pregnancy is marked by immunomodulation which can interfere with immune reactions. A better understanding of the immunological mechanisms in the mother and of the immunity transmitted to the fetus is necessary to better understand the maternal-fetal issues of COVID 19.
This prospective study concerns patients presenting for their delivery at Foch Hospital.
4 groups of patients will be identified in the delivery room after childbirth based on their COVID 19 PCR taken within 72 hours, their COVID 19 serology, or a history of positive COVID 19 PCR during pregnancy : 1 control group of 50 patients, 1 group of 50 asymptomatic patients, 1 group of 50 patients with symptoms, and 1 group of 50 cured patients who contracted the disease during pregnancy. The patients will have various samples: blood, umbilical cord blood, umbilical cord, placenta
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control patients | Other | Other: Specimens specific for the studyControl patients (negative serology and PCR) |
| asymptomatic patients | Other | Other: Specimens specific for the studyasymptomatic patients (PCR positive) |
| symptomatic patients | Other | Other: Specimens specific for the studysymptomatic patients (PCR positive) |
| Cured patients | Other | Other: Specimens specific for the studycured patients who contracted the disease during pregnancy (positive serology in the 15 days preceding childbirth or history of positive PCR during pregnancy and negative PCR within 72 hours) |
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)
- Patient pregnant for more than 20 weeks with amenorrhea
- Having completed a COVID 19 PCR within 72 hours
- Admitted to the birthing room at Foch hospital for her delivery
Key exclusion criteria (6 listed)
- Minor (age <18 years, on inclusion)
- Diabetes with and without insulin (only for the control group)
- High blood pressure (only for the control group),
- Preeclampsia (only for the control group)
- Infection during pregnancy: HIV, toxoplasmosis, rubella, CMV, syphilis.
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 |
|---|---|---|
| Specimens specific for the studySpecimens (blood, umbilical cord, umbilical cord blood, placenta) | Other | Control patients, Cured patients, asymptomatic patients, symptomatic patients |
Primary outcome
Placental histological evaluation
Time frame: Delivery Day 0-Day1
vascular hypoperfusion on the fetal and maternal side, thrombosis and other abnormalities
6 secondary outcomes
Cellular analysis on maternal blood and cord blood: phenotyping from PBMCs and NFS with the characterization of lymphocyte populations by the CytodiffTM technique
Time frame: Delivery Day 0 - Day 1
Cellular analysis on maternal blood and cord blood: functional activities from PBMCs and NFS with the characterization of lymphocyte populations by the CytodiffTM technique
Time frame: Delivery Day 0 - Day 1
Number of cytokines in maternal blood and cord blood
Time frame: Delivery Day 0 - Day 1
Number of immunoglobulins in maternal and fetal blood
Time frame: Delivery Day 0 - Day 1
Maternal clinical evaluation then neonatal on medical file and telephone questionnaire 1 month after childbirth. Comparison of results between groups.
Time frame: 1 month postpartum Day 30
Foetal clinical evaluation then neonatal on medical file and telephone questionnaire 1 month after childbirth. Comparison of results between groups.
Time frame: 1 month postpartum Day 30
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 7 Jun 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specimens specific for the study in people with Covid19, run by Hopital Foch 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 6 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 7 Jun 2024. 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?
Placental histological evaluation (time frame: Delivery Day 0-Day1). 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 7 Jun 2024.