COVID-19 and Pregnancy: Placental and Immunological Impacts (MaterCov)

Hopital Foch

Status: Completed

Conditions: Covid19

Treatments: Other: Specimens specific for the study

Study type: Interventional

Funder types: Other

Identifiers

NCT04726111

2020_0170

Details and patient eligibility

About

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

Full 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

Enrollment: 59 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 4 patient groups

Control patients

Other group

Description:

Control patients (negative serology and PCR)

Treatment:

Other: Specimens specific for the study

asymptomatic patients

Other group

Description:

asymptomatic patients (PCR positive)

Treatment:

Other: Specimens specific for the study

symptomatic patients

Other group

Description:

symptomatic patients (PCR positive)

Treatment:

Other: Specimens specific for the study

Cured patients

Other group

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)

Treatment:

Other: Specimens specific for the study