COVID-19 and Pregnancy: Placental and Immunological Impacts

Covid19 Clinical Trial

— MaterCov  

Official title:

COVID-19 and Pregnancy: Placental and Immunological Impacts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04726111
• Other study ID #: 2020_0170
• Status: Completed
• Phase: N/A
• Start date: December 30, 2020
• Est. completion date: September 8, 2021

Study information

• Verified date: June 2024
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 8, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• Specimens specific for the study
Specimens (blood, umbilical cord, umbilical cord blood, placenta)

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Placental histological evaluation	vascular hypoperfusion on the fetal and maternal side, thrombosis and other abnormalities	Delivery Day 0-Day1
Secondary	Cellular analysis on maternal blood and cord blood: phenotyping from PBMCs and NFS with the characterization of lymphocyte populations by the CytodiffTM technique		Delivery Day 0 - Day 1
Secondary	Cellular analysis on maternal blood and cord blood: functional activities from PBMCs and NFS with the characterization of lymphocyte populations by the CytodiffTM technique		Delivery Day 0 - Day 1
Secondary	Number of cytokines in maternal blood and cord blood		Delivery Day 0 - Day 1
Secondary	Number of immunoglobulins in maternal and fetal blood		Delivery Day 0 - Day 1
Secondary	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.	1 month postpartum Day 30
Secondary	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.	1 month postpartum Day 30