NCT04726111

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2020

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2021

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

January 21, 2021

Last Update Submit

June 6, 2024

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • Placental histological evaluation

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

    Delivery Day 0-Day1

Secondary Outcomes (6)

  • 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.

    1 month postpartum Day 30

  • +1 more secondary outcomes

Study Arms (4)

Control patients

OTHER

Control patients (negative serology and PCR)

Other: Specimens specific for the study

asymptomatic patients

OTHER

asymptomatic patients (PCR positive)

Other: Specimens specific for the study

symptomatic patients

OTHER

symptomatic patients (PCR positive)

Other: Specimens specific for the study

Cured patients

OTHER

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

Interventions

Specimens specific for the studyOTHER

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

Control patientsCured patientsasymptomatic patientssymptomatic patients

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2021

First Posted

January 27, 2021

Study Start

December 30, 2020

Primary Completion

July 30, 2021

Study Completion

September 8, 2021

Last Updated

June 7, 2024

Record last verified: 2024-06

Locations

FR(1)