Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

COVID 19 ANTOBODIES IN PREGNANT WOMEN AND THEIR CONNECTION TO BETA CELL FUNCTION IN THE FETUS

26. april 2021 opdateret af: Mirra Manevich Mazor, Maaynei Hayesha Medical Center

DOES COVID-19 INFECTION AND/OR VACCINATION OF PREGNANT WOMEN AFFECT THE PANCREATIC BETA CELLS OF THE FETUS BECOMING A TRIGGER FOR FUTURE DEVELOPMENT OF CHILDHOOD TYPE 1 DIABETES

The aim of this study is to check for the presence of COVID 19 antibodies [Covid-19, GAD-65, IA-2, ICA] in the blood of laboring women who have been exposed to either the virus itself or to the vaccine during pregnancy . The same test will be done on cord blood. Then the types of antibodies will be compared, between maternal and neonatal blood. The blood will be taken along with routine blood tests without additional punctures of Mother or Baby.

Studieoversigt

Detaljeret beskrivelse

T1D is caused by an autoimmune reaction to proteins that cause the destruction of the pancreatic beta cells. The incidence of childhood Type 1 diabetes (T1D) is continuously increasing, caused by environmental factors, mainly viruses (1).

The most implicated viruses are coxsackie B4 (2) and rotaviruses (3,4). In the past mumps and rubella viruses gave been found to cause early childhood T1D and the introduction of mumps and rubella vaccination have stopped this process (5).

Recently we (6) and others (7-9) have shown that Rotavirus vaccination to infants attenuates the incidence of T1D in children aged 0-5 (in press). Covid-19 has not yet been investigated.

Aim of study To determine whether anti-Covid-19 antibodies generated by infection and/or vaccination of pregnant mothers, pass the placenta and affect the fetal beta-cells, by damaging or protecting these insulin producing cells.

Subjects 100 pregnant women with Covid-19 infection or vaccination who are followed and delivered at the Mayanei HaYeshua Medical Center will be enrolled in the study.

Method

Blood from the pregnant mothers will be taken at delivery (and before if possible) as well as from the cordblood. The following βcell specific antibodies will be tested in the laboratory of the Schneider Children's Hospital:

Covid-19, GAD-65, IA-2, ICA. (ml blood from the mother and 1ml cordblood) The bloods will have to be centrifuged within 20-30 minutes and the sera kept at -20ºC until delivery.

Background Whether the Covid-19 epidemic affects childhood T1D is controversial (10). Flannery et al (11) and Atyeo et al., reported that SARS-Cov-2 infected mothers transmit SARS-Cov-2 antibodies via the placenta to the fetus Fernandez reported protective Covid-19 antibodies in breast milk of infected mothers (13). Kamrath et al from Germany (14) and Rabbone et al from Italy (15) reported a high prevalence of DKA in children diagnosed with T1D during the recent pandemic.

As the Covid-19 virus with its various mutations is known to affect several organs and cells in the human body it is of great interest to know whether it affects also the pancreatic βcells of the fetus.

Hypothesis We assume that unvaccinated mothers transfer the virus antibodies to the fetus, and which may be the first damage to the βcells endangering future development of future type 1 childhood diabetes. Transfer of Covid protecting antibodies may beneficially affect the infant at risk.

Discussion and importance of the study To the best of our knowledge, no such study has been performed.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Merkaz
      • Bnei Brak, Merkaz, Israel
        • Rekruttering
        • Maayanei Hayeshua Medical Center
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 48 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

pregnant women delivery a live infant who were exposed or vaccinated to COVID 19

Beskrivelse

Inclusion Criteria:

  • exposure to the COVID 19 virus or vaccine during pregnancy

Exclusion Criteria:

- Age under 18 or over 48 IUFD

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
covid exposed
women who were exposed to covid 19 during pregnancy
no intervention, observation only
covid vaccinated
women who were vaccinated to covid 19 during pregnancy
no intervention, observation only

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Presence of anti COVID 19 antibodies in maternal and cord blood
Tidsramme: ONE YEAR
Covid-19, GAD-65, IA-2, ICA
ONE YEAR

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. april 2021

Primær færdiggørelse (Forventet)

1. januar 2022

Studieafslutning (Forventet)

1. juli 2022

Datoer for studieregistrering

Først indsendt

26. april 2021

Først indsendt, der opfyldte QC-kriterier

26. april 2021

Først opslået (Faktiske)

27. april 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

IF YOU ASK NICELY WE'LL CONSIDER SHARING

IPD-delingstidsramme

ONE YEAR

IPD-deling Understøttende informationstype

  • Studieprotokol
  • Formular til informeret samtykke (ICF)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med no intervention, observation only

Abonner