Study of General Foetal Movements Using Ultrasound

NCT07868185 | Recruiting

• 1 other identifier: 2022-A01666-37
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pregnant Woman; Foetus Abnormal General Movements

Keywords

Ultrasound recordings; General Movements Grid; Autism spectrum disorders in the foetus; Neurodevelopmental deficits in the foetus

Outcome Measures

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.

  9 months

Secondary Outcomes (2)

• General Movement Patterns at 0 to 4 Weeks and 11 to 16 Weeks After Birth Assessed From Video Recordings

  Week 4 and week 16

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

  Year 1 and year 2

Study Arms (1)

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.

Procedure: External or endovaginal ultrasound

Interventions

External or endovaginal ultrasound PROCEDURE

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.

Pregnant women treated in the gynaecology-obstetrics department

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Pathological pregnancy
• Under guardianship, curatorship or legal protection.

Sponsors & Collaborators

• François FARGES: lead

Study Sites (1)

Groupe Hospitalier Diaconesses Croix Saint-Simon

Paris, Paris, 75012, France

RECRUITING

Central Study Contacts

Djazia Bouzelmat, Clinical Research Assistant

CONTACT

01 44 64 30 98; dbouzelmat@hopital-dcss.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: gynaecologist

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: October 9, 2026
• Study Start: February 14, 2023
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): February 14, 2029
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

FR (1)