Health TrialsbyHealthPanel

Study of General Foetal Movements Using Ultrasound

ConditionsPregnant WomanFoetus Abnormal General Movements
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFrançois FARGES

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Pathological pregnancy

Under guardianship, curatorship or legal protection.

Trial design

Design model

Single group

Treatments tested in this trial

  • External or endovaginal ultrasound

    Procedure/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.

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: Pregnant women treated in the gynaecology-obstetrics departmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
9 months

Secondary outcomes

1

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
2

Child Development Scores Assessed by Pediatric Developmental Questionnaires at 12 and 24 Months of Age

Time frame
Year 1 and year 2

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

François FARGES

Lead sponsor

Groupe Hospitalier Diaconesses Croix Saint-Simon

Sponsor institution

Source ClinicalTrials.gov
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