COVID-19 and Pregnancy: Placental and Immunological Impacts (MaterCov)
Primary Purpose
Covid19
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Specimens specific for the study
Sponsored by
About this trial
This is an interventional other trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Hopital FochRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Control patients
asymptomatic patients
symptomatic patients
Cured patients
Arm Description
Control patients (negative serology and PCR)
asymptomatic patients (PCR positive)
symptomatic patients (PCR positive)
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)
Outcomes
Primary Outcome Measures
Placental histological evaluation
vascular hypoperfusion on the fetal and maternal side, thrombosis and other abnormalities
Secondary Outcome Measures
Cellular analysis on maternal blood and cord blood: phenotyping from PBMCs and NFS with the characterization of lymphocyte populations by the CytodiffTM technique
Cellular analysis on maternal blood and cord blood: functional activities from PBMCs and NFS with the characterization of lymphocyte populations by the CytodiffTM technique
Number of cytokines in maternal blood and cord blood
Number of immunoglobulins in maternal and fetal blood
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04726111
Brief Title
COVID-19 and Pregnancy: Placental and Immunological Impacts
Acronym
MaterCov
Official Title
COVID-19 and Pregnancy: Placental and Immunological Impacts
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 30, 2020 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control patients
Arm Type
Other
Arm Description
Control patients (negative serology and PCR)
Arm Title
asymptomatic patients
Arm Type
Other
Arm Description
asymptomatic patients (PCR positive)
Arm Title
symptomatic patients
Arm Type
Other
Arm Description
symptomatic patients (PCR positive)
Arm Title
Cured patients
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Specimens specific for the study
Intervention Description
Specimens (blood, umbilical cord, umbilical cord blood, placenta)
Primary Outcome Measure Information:
Title
Placental histological evaluation
Description
vascular hypoperfusion on the fetal and maternal side, thrombosis and other abnormalities
Time Frame
Delivery Day 0-Day1
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Number of cytokines in maternal blood and cord blood
Time Frame
Delivery Day 0 - Day 1
Title
Number of immunoglobulins in maternal and fetal blood
Time Frame
Delivery Day 0 - Day 1
Title
Maternal clinical evaluation then neonatal on medical file and telephone questionnaire 1 month after childbirth. Comparison of results between groups.
Description
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.
Time Frame
1 month postpartum Day 30
Title
Foetal clinical evaluation then neonatal on medical file and telephone questionnaire 1 month after childbirth. Comparison of results between groups.
Description
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.
Time Frame
1 month postpartum Day 30
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Carbonnel, MD
Phone
+331 46 25 48 53
Email
m.carbonnel@hopital-foch.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth Hulier-Ammar
Phone
+33 1 46 25 11 75
Email
drci-promotion@hopital-foch.com
Facility Information:
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Carbonnel
Phone
+331 46 25 48 53
Email
m.carbonnel@hopital-foch.com
12. IPD Sharing Statement
Learn more about this trial
COVID-19 and Pregnancy: Placental and Immunological Impacts
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