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

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

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: Specimens specific for the study

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

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Suresnes, France, 92150
    • Hopital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control patients; Control patients (negative serology and PCR)	Other: Specimens specific for the study; Specimens (blood, umbilical cord, umbilical cord blood, placenta)
Other: asymptomatic patients; asymptomatic patients (PCR positive)	Other: Specimens specific for the study; Specimens (blood, umbilical cord, umbilical cord blood, placenta)
Other: symptomatic patients; symptomatic patients (PCR positive)	Other: Specimens specific for the study; Specimens (blood, umbilical cord, umbilical cord blood, placenta)
Other: Cured patients; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Placental histological evaluation	vascular hypoperfusion on the fetal and maternal side, thrombosis and other abnormalities	Delivery Day 0-Day1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Number of cytokines in maternal blood and cord blood		Delivery Day 0 - Day 1
Number of immunoglobulins in maternal and fetal blood		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.	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.	1 month postpartum Day 30

Collaborators and Investigators

• Sponsor: Hopital Foch

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2020
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): September 8, 2021

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020_0170

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No