Clinical trial NCT04726111: COVID-19 and Pregnancy: Placental and Immunological Impacts
Official title: COVID-19 and Pregnancy: Placental and Immunological Impacts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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

Primary outcomes:
measure: Placental histological evaluation
timeFrame: Delivery Day 0-Day1
Secondary outcomes:
measure: Cellular analysis on maternal blood and cord blood: phenotyping from PBMCs and NFS with the characterization of lymphocyte populations by the CytodiffTM technique
timeFrame: Delivery Day 0 - Day 1
measure: Cellular analysis on maternal blood and cord blood: functional activities from PBMCs and NFS with the characterization of lymphocyte populations by the CytodiffTM technique
timeFrame: Delivery Day 0 - Day 1
measure: Number of cytokines in maternal blood and cord blood
timeFrame: Delivery Day 0 - Day 1
measure: Number of immunoglobulins in maternal and fetal blood
timeFrame: Delivery Day 0 - Day 1
measure: Maternal clinical evaluation then neonatal on medical file and telephone questionnaire 1 month after childbirth. Comparison of results between groups.
timeFrame: 1 month postpartum Day 30
measure: Foetal clinical evaluation then neonatal on medical file and telephone questionnaire 1 month after childbirth. Comparison of results between groups.
timeFrame: 1 month postpartum Day 30
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
References: