Pregnant WomanFETAL-GMsNCT07868185
Study of General Foetal Movements Using Ultrasound
A study testing External or endovaginal ultrasound in people with Pregnant Woman and Foetus Abnormal General Movements, run by François FARGES at 1 site in France.
Trial summary
This research explores General Movements (GMs) in a reference population. Abnormal general movements in babies are predictive of autism spectrum disorders or neurodevelopmental deficits. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Woman, Foetus Abnormal General Movements
- What is being tested?
- External or endovaginal ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 14 Feb 2023to 14 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient aged over 18
- Pregnant from 13 weeks of amenorrhoea
- Indication for an ultrasound scan as part of the usual monitoring of her pregnancy
- With no particular history or who has had a child with autism spectrum disorders or neurodevelopmental disorders
- Able to understand the benefits and constraints of the research
- Having given signed consent to participate, as well as that of his/her spouse.
- Beneficiary of a social security scheme or entitled person (excluding AME).
Who cannot join
- Pathological pregnancy
- Under guardianship, curatorship or legal protection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, Paris, 75012
Djazia BOUZELMAT, Clinical Research Assistant, 0144643098, dbouzelmat@hopital-dcss.org
François FARGES, Doctor
About this study
Official title: Ultrasound Study of the Foetus's General Movements
This research explores General Movements (GMs) in a reference population. Abnormal general movements in babies are predictive of autism spectrum disorders or neurodevelopmental deficits.
General movements have received little attention in the context of foetuses, which is why developing a reading grid to analyse general movements in foetuses could be a valuable tool for facilitating early diagnosis and prompt treatment of at-risk babies.
Read the detailed description
The identification of General Movements (GMs) in utero is not common practice among ultrasound technicians. However, it has been shown that poor or abnormal general movements in premature or full-term infants is a marker of the risk of later developing autism spectrum disorders or neurodevelopmental disorders. Prenatal screening currently focuses on detecting morphological malformations rather than the quality of general movements. Movement stimulates brain development through epigenetic action, and ultrasound enables this development to be monitored during pregnancy. General movements have been little studied in the foetus, and the introduction of a reading grid enabling general movements to be identified in utero could provide a new tool for ultrasound scanners in identifying risk situations at perinatal and/or postnatal level.
The investigators hypothesise that analysing ultrasound recordings as part of this research could lead to the creation of a grid to help identify general movements in utero. This would be a first step towards introducing a new tool for ultrasound technicians to use in the early detection of autism spectrum disorders or neurodevelopmental deficits.
- Conditions
- Pregnant Woman, Foetus Abnormal General Movements
- Being tested
- External or endovaginal ultrasound
- Keywords
- Ultrasound recordings, General Movements Grid, Autism spectrum disorders in the foetus, Neurodevelopmental deficits in the foetus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External or endovaginal ultrasoundProcedure or surgery
Endovaginal or external ultrasound specifically for research at 13, 17 (if amniocentesis), 23 and 33 weeks of amenorrhoea (+/- 10 days) (on average 10% endovaginal / 90% external ultrasound). Each patient will undergo one to four additional ultrasound scans.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women treated in the gynaecology-obstetrics department | Experimental | In addition to the standard follow-up ultrasound, pregnant participants treated in the gynaecology-obstetrics department, will be offered a research-specific endovaginal or external ultrasound at 13, 17 (if an amniocentesis is performed), 23 and 33 weeks of amenorrhoea (±10 days). On average, 10% of ultrasounds are endovaginal and 90% are external. Receives: Procedure: External or endovaginal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative and Qualitative Parameters of General Fetal Movements Assessed by Ultrasound Recordings Across Gestation
Presence, frequency, and characteristics of abnormal fetal movement patterns identified on ultrasound recordings obtained at 13, 17, 23, and 33 weeks of amenorrhea (±10 days). Recordings will be independently assessed by experts in fetal ultrasonography and General Movements Assessment using the General Movements Assessment grid adapted for preterm infants. Reported outcomes will include the occurrence and type of abnormal movement patterns at each assessment time point.
Measured: 9 months
Secondary outcomes (2)
General Movement Patterns at 0 to 4 Weeks and 11 to 16 Weeks After Birth Assessed From Video Recordings
Measured: Week 4 and week 16
Child Development Scores Assessed by Pediatric Developmental Questionnaires at 12 and 24 Months of Age
Measured: Year 1 and year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start14 Feb 2023
- Primary completion14 Feb 2027 (estimated)
- Study completion14 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- François FARGES
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, François FARGES, Groupe Hospitalier Diaconesses Croix Saint-Simon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868185
- Sponsor's protocol ID
- 2022-A01666-37
- Acronym
- FETAL-GMs
- Status last verified
- Oct 2026
- First submitted
- 27 Apr 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Study of the Foetus's General Movements
- ClinicalTrials.gov ID
- NCT07868185
- Acronym / sponsor ID
- FETAL-GMs / 2022-A01666-37
- Conditions
- Pregnant Woman, Foetus Abnormal General Movements
- Keywords
- Ultrasound recordings, General Movements Grid, Autism spectrum disorders in the foetus, Neurodevelopmental deficits in the foetus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- François FARGESUniversity, hospital or other
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 14 Feb 2027 (estimated)
- Study completion
- 14 Feb 2029 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research explores General Movements (GMs) in a reference population. Abnormal general movements in babies are predictive of autism spectrum disorders or neurodevelopmental deficits.
General movements have received little attention in the context of foetuses, which is why developing a reading grid to analyse general movements in foetuses could be a valuable tool for facilitating early diagnosis and prompt treatment of at-risk babies.
Detailed description
The identification of General Movements (GMs) in utero is not common practice among ultrasound technicians. However, it has been shown that poor or abnormal general movements in premature or full-term infants is a marker of the risk of later developing autism spectrum disorders or neurodevelopmental disorders. Prenatal screening currently focuses on detecting morphological malformations rather than the quality of general movements. Movement stimulates brain development through epigenetic action, and ultrasound enables this development to be monitored during pregnancy. General movements have been little studied in the foetus, and the introduction of a reading grid enabling general movements to be identified in utero could provide a new tool for ultrasound scanners in identifying risk situations at perinatal and/or postnatal level.
The investigators hypothesise that analysing ultrasound recordings as part of this research could lead to the creation of a grid to help identify general movements in utero. This would be a first step towards introducing a new tool for ultrasound technicians to use in the early detection of autism spectrum disorders or neurodevelopmental deficits.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women treated in the gynaecology-obstetrics department | Experimental | Procedure: External or endovaginal ultrasoundIn addition to the standard follow-up ultrasound, pregnant participants treated in the gynaecology-obstetrics department, will be offered a research-specific endovaginal or external ultrasound at 13, 17 (if an amniocentesis is performed), 23 and 33 weeks of amenorrhoea (±10 days). On average, 10% of ultrasounds are endovaginal and 90% are external. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient aged over 18
- Pregnant from 13 weeks of amenorrhoea
- Indication for an ultrasound scan as part of the usual monitoring of her pregnancy
- With no particular history or who has had a child with autism spectrum disorders or neurodevelopmental disorders
- Able to understand the benefits and constraints of the research
Key exclusion criteria (2 listed)
- Pathological pregnancy
- Under guardianship, curatorship or legal protection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External or endovaginal ultrasoundEndovaginal or external ultrasound specifically for research at 13, 17 (if amniocentesis), 23 and 33 weeks of amenorrhoea (+/- 10 days) (on average 10% endovaginal / 90% external ultrasound). Each patient will undergo one to four additional ultrasound scans. | Procedure or surgery | Pregnant women treated in the gynaecology-obstetrics department |
Primary outcome
Quantitative and Qualitative Parameters of General Fetal Movements Assessed by Ultrasound Recordings Across Gestation
Time frame: 9 months
Presence, frequency, and characteristics of abnormal fetal movement patterns identified on ultrasound recordings obtained at 13, 17, 23, and 33 weeks of amenorrhea (±10 days). Recordings will be independently assessed by experts in fetal ultrasonography and General Movements Assessment using the General Movements Assessment grid adapted for preterm infants. Reported outcomes will include the occurrence and type of abnormal movement patterns at each assessment time point.
2 secondary outcomes
General Movement Patterns at 0 to 4 Weeks and 11 to 16 Weeks After Birth Assessed From Video Recordings
Time frame: Week 4 and week 16
Child Development Scores Assessed by Pediatric Developmental Questionnaires at 12 and 24 Months of Age
Time frame: Year 1 and year 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External or endovaginal ultrasound in people with Pregnant Woman and Foetus Abnormal General Movements, run by François FARGES at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Djazia Bouzelmat, Clinical Research Assistant (01 44 64 30 98, dbouzelmat@hopital-dcss.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative and Qualitative Parameters of General Fetal Movements Assessed by Ultrasound Recordings Across Gestation (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.