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Completed

NCT Number: NCT04726111

COVID-19 and Pregnancy: Placental and Immunological Impacts

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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Foch

Suresnes, 92150, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Specimens specific for the study

Other

Specimens (blood, umbilical cord, umbilical cord blood, placenta)

Primary outcomes

  1. Placental histological evaluation

    Time frame: Delivery Day 0-Day1

    vascular hypoperfusion on the fetal and maternal side, thrombosis and other abnormalities

Secondary outcomes

  1. 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

  2. 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

  3. Number of cytokines in maternal blood and cord blood

    Time frame: Delivery Day 0 - Day 1

  4. Number of immunoglobulins in maternal and fetal blood

    Time frame: Delivery Day 0 - Day 1

  5. Maternal clinical evaluation then neonatal on medical file and telephone questionnaire 1 month after childbirth. Comparison of results between groups.

    Time frame: 1 month postpartum Day 30

    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.

  6. Foetal clinical evaluation then neonatal on medical file and telephone questionnaire 1 month after childbirth. Comparison of results between groups.

    Time frame: 1 month postpartum Day 30

    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.

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: MaterCov

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2021
Registry last updated
Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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