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Could pregnancy exposures shape neurodevelopment? massive study aims to find out

NCT ID NCT05681923

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 1,200 families who already have a child with autism (high-risk group) and 500 families from the general population (low-risk group) starting from early pregnancy. Researchers collect biological samples and survey data to explore how genetics, environment, diet, and lifestyle may influence the development of autism and other neurodevelopmental disorders. Children are monitored until age 6, when diagnoses can be reliably made.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this research could identify early risk factors and pave the way for earlier detection and intervention for autism and related conditions.
What could go wrong
This is an observational study, not a treatment trial. It may take years to yield actionable insights, and findings may not apply to all populations.

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.

Participants

About 7,320 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Mar 2034

An estimate. End dates often move.

Lead sponsor

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.

Who is studied

Low risk cohort is a community based sample. High risk cohort is a community based sample as well as an active list of patients followed in specialized department in the management of children with neurodevelopmental disorders. The persons involved in the study are the pregnant woman, her partner (if he is the biological father of the unborn child and lives with the mother), the newborn child, and the older sibling with autism.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

INCLUSION CRITERIA: General inclusion criteria (High risk and Low risk cohorts) Mother: * Be pregnant (single or multiple pregnancy), at least 16 weeks of amenorrhea, * Have at least one biological child of 24 months or older, * At least 18 years of age Father: * Be the biological father of the unborn child, * At least 18 years of age Unborn Child: \- Have a woman study participant as mother. Specific inclusion criteria for the High risk cohort: * Autistic sibling: refers to the biological child(ren) of the mother and/or father participating in the study and being the parent(s) of the unborn child * Be at least 24 months old and less than 18 years old, * Have a confirmed diagnosis of Autism Spectrum Disorder based on medical records. If in doubt, the SRS-2 (Social Responsiveness Scale for Adults) and PEDS-DM (Parents' Evaluation of developmental status) questionnaires will be completed. Only children with positive scores on one of these questionnaires will be included after validation of the diagnosis by an expert committee, * In case of several children with Autism Spectrum Disorder based in the siblings, only the last born will be included. Remarks: * Autism Spectrum Disorder siblings resulting from a medically assisted procreation are eligible provided that part of the genetic heritage is common to that of the mother or father of the unborn child participating in the study. * If the father does not live with the mother of the unborn child, his participation is not required and does not preclude the participation of other family members. EXCLUSION CRITERIA: General non-inclusion criteria (High risk and Low risk cohorts): Father and mother: * Unable to understand French or the study questionnaires * Participant on protective measures (guardianship or curatorship) or deprived of liberty by judicial or administrative decision, or subject to a legal protection measure * Not affiliated to a social security system * Refusal to participate. In the case of consent given for the born and unborn child, the consent must be given by the person(s) with parental authority. * Live at a distance from the recruitment center incompatible with follow-up. Specific non-inclusion criteria for the Low risk cohort: Mother and/or father of unborn child: \- Have a biological child with a diagnosis of Autism Spectrum Disorder or other neuro developmental disorder

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Montpellier

    RECRUITING

    Montpellier, 34 090, France

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