NCT04860908

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 26, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 26, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

8 months

First QC Date

April 26, 2021

Last Update Submit

April 26, 2021

Conditions

Generation of Anti COVID-19 Antibodies in a Fetus, Whose Mother Was Exposed to COVID or Was Vaccinated During Pregnancy

Keywords

covid-19 , antibodies, pregnancy, covid-19 vaccine, cord blood

Outcome Measures

Primary Outcomes (1)

  • Presence of anti COVID 19 antibodies in maternal and cord blood

    Covid-19, GAD-65, IA-2, ICA

    ONE YEAR

Study Arms (2)

covid exposed

women who were exposed to covid 19 during pregnancy

Other: no intervention, observation only

covid vaccinated

women who were vaccinated to covid 19 during pregnancy

Other: no intervention, observation only

Interventions

no intervention, observation onlyOTHER

no intervention, observation only

covid exposedcovid vaccinated

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsanyone with a uterus with a fetus in it may apply, gender identity not important
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • exposure to the COVID 19 virus or vaccine during pregnancy

You may not qualify if:

  • \- Age under 18 or over 48 IUFD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maayanei Hayeshua Medical Center

Bnei Brak, Central District, Israel

RECRUITING

Related Publications (1)

  • 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.

    PMID: 27020257BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mirra Manevich, MD

CONTACT

0526001068mirra.manevich@gmail.com

Bari Kaplan, Prof

CONTACT

0505200143prof@barikaplan.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
OBSTETRICS & GYNECOLOGY RESIDENT

Study Record Dates

First Submitted

April 26, 2021

First Posted

April 27, 2021

Study Start

April 26, 2021

Primary Completion

January 1, 2022

Study Completion

July 1, 2022

Last Updated

April 27, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

IF YOU ASK NICELY WE'LL CONSIDER SHARING

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
ONE YEAR

Locations

IL(1)