COVID 19 ANTOBODIES IN PREGNANT WOMEN AND THEIR CONNECTION TO BETA CELL FUNCTION IN THE FETUS
NCT ID: NCT04860908
Last Updated: 2021-04-27
Study Results
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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UNKNOWN
100 participants
OBSERVATIONAL
2021-04-26
2022-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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covid exposed
women who were exposed to covid 19 during pregnancy
no intervention, observation only
no intervention, observation only
covid vaccinated
women who were vaccinated to covid 19 during pregnancy
no intervention, observation only
no intervention, observation only
Interventions
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no intervention, observation only
no intervention, observation only
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
48 Years
FEMALE
Yes
Sponsors
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Maaynei Hayesha Medical Center
OTHER
Responsible Party
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Mirra Manevich Mazor
OBSTETRICS & GYNECOLOGY RESIDENT
Locations
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Maayanei Hayeshua Medical Center
Bnei Brak, Central District, Israel
Countries
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Central Contacts
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Facility Contacts
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References
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Op de Beeck A, Eizirik DL. Viral infections in type 1 diabetes mellitus--why the beta cells? Nat Rev Endocrinol. 2016 May;12(5):263-273. doi: 10.1038/nrendo.2016.30. Epub 2016 Mar 29.
Other Identifiers
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MaayneiHMC
Identifier Type: -
Identifier Source: org_study_id
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