Can a new blood test catch congenital toxoplasmosis earlier?
NCT ID NCT03385499
First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time
Summary
This trial evaluates a new blood test (ELISPOT) that looks for immune cells in a newborn's cord blood that produce antibodies against the Toxoplasma parasite. The goal is to see if this test can diagnose congenital toxoplasmosis—an infection passed from mother to baby during pregnancy—more accurately and earlier than current methods. The study includes pregnant women with recent infection, past infection, or no infection, and compares test results across these groups.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ELISPOT blood test to detect newborn immune cells producing Toxoplasma-specific antibodies
- What this could lead to
- If successful, this could lead to a faster, more reliable diagnostic test for congenital toxoplasmosis, enabling earlier treatment and better outcomes for infected newborns.
- What could go wrong
- This is a small, early-stage diagnostic study, so the test may not prove accurate enough or practical for routine use. It is not a treatment trial and offers no direct benefit to participants.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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70 people
The number who actually took part.
- Started
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Jun 2018
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: In all cases, pregnant women whose age ≥ 18 years are concerned. * Seroconversion group: a diagnosis of toxoplasmic seroconversion will be documented by a negative serology in early pregnancy which becomes positive during pregnancy, with the synthesis of specific IgG; * Positive control group: known and documented positive toxoplasmosis serology; * Negative control group: known and documented negative serology for toxoplasmosis at 7 months of pregnancy. Exclusion Criteria: Non-inclusion criteria common to the three groups * Expected delivery in another maternity that does not participate in the study; * Positive serology for HIV; * Contra-indication to additional tubes during the blood sampling corresponding to the usual follow-up of pregnancy (anemia, all other case according to the evaluation of the clinician in charge of the follow-up); * Absence of social insurance or CMU or AME; * Vulnerable pregnant woman (under guardianship or curatorship); * No signature of consent to participate in research.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hopital Bichat
Paris, France
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Hopital Cochin
Paris, France
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Hopital Louis Mourier
Colombes, 92700, France
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