COVID-19 and Pregnancy: Placental and Immunological Impacts

NCT ID: NCT04726111

Last Updated: 2024-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-30

Study Completion Date

2021-09-08

Brief Summary

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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

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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

Conditions

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Covid19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control patients

Control patients (negative serology and PCR)

Group Type OTHER

Specimens specific for the study

Intervention Type OTHER

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

asymptomatic patients

asymptomatic patients (PCR positive)

Group Type OTHER

Specimens specific for the study

Intervention Type OTHER

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

symptomatic patients

symptomatic patients (PCR positive)

Group Type OTHER

Specimens specific for the study

Intervention Type OTHER

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

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)

Group Type OTHER

Specimens specific for the study

Intervention Type OTHER

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

Interventions

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Specimens specific for the study

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hopital Foch

Suresnes, , France

Site Status

Countries

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France

Other Identifiers

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2020_0170

Identifier Type: -

Identifier Source: org_study_id

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