An interventional study of Specimens specific for the study in Covid19, sponsored by Hopital Foch. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-07.
Sponsored by Hopital Foch · Not applicable, Interventional, and Other
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
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
7,775 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 59 is below the median of 100 across 4,175 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Hopital Foch is the lead sponsor of 215 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
Control patients (negative serology and PCR)
Other: Specimens specific for the study
asymptomatic patients (PCR positive)
Other: Specimens specific for the study
symptomatic patients (PCR positive)
Other: Specimens specific for the study
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)
Other: Specimens specific for the study
Specimens (blood, umbilical cord, umbilical cord blood, placenta)
Placental histological evaluation
vascular hypoperfusion on the fetal and maternal side, thrombosis and other abnormalities
Time frame: Delivery Day 0-Day1
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.
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
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.
Time frame: 1 month postpartum Day 30
Ran from Dec 2020 to primary completion in Jul 2021, 7 months.
Of 1,295 non-industry interventional studies with no phase under COVID-19, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 20. This study's 7 months is below that.
Counting every sponsor, half of 1,425 studies reached it within 9 months; a quarter within 3 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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