An interventional study of Questionnaires in Neurodevelopmental Disorders, sponsored by University Hospital, Bordeaux. Not yet recruiting at 1 site in France. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Prevention
In France, the rate of labor induction has markedly increased in recent years, partly following the ARRIVE trial suggesting short-term benefits of elective induction at 39 weeks in low-risk nulliparous women. This trial is currently being replicated in France (FRENCH-ARRIVE), as maternal characteristics, cesarean rates, and healthcare organization differ from the US. Importantly, no comparative data exist on the mid-term consequences of reducing gestational age at delivery with elective induction of labor-from 41 to 39 weeks-versus usual expectant management on child health and maternal outcomes. Generating such evidence is essential to inform decision making for women reaching 39 weeks of gestation, i.e. the large majority of pregnant women
In France, the rate of labor induction increased from 20% to 25% of deliveries between 2016 and 2021. This recently dramatic increase also reported in other high income settings, is likely in part related to the publication of the ARRIVE trial (Grobman, NEJM 2018). Before it, induction of labor was usually proposed in case of condition potentially associated to a higher maternal or fetal risk with expectant management compared with an immediate delivery. The ARRIVE trial, a multicenter, randomized, controlled trial suggests a short-term maternal-fetal benefit to systematic induction of labor at 39 weeks of gestation (experimental arm) compared to an expectant management (control arm) in low-risk nulliparous women, with a decreasing trend of adverse perinatal outcome and a significant lower risk of cesarean delivery and maternal hypertensive disorders. Because the generalizability of these results in US outside settings is unknown (as the maternal characteristics, national rate of cesareans and organization and access of care differ in US from an European country including France, this trial is currently replicating in France (FRENCH-ARRIVE trial, PHRCN n° 19-0063) (Sentilhes et al, Lancet 2023; Azria et al, AJOG 2023;)
Regardless of its results (which are not yet available), mid-term follow-up of children born to mothers enrolled in the FRENCH-ARRIVE trial, through the FAMILY-FA project, is crucial:
1 / In absence of comparative data, it remains unknown whether the mid-term child health differs or not according to the late pregnancy management, through the bias of reduction the gestational age at delivery from 41 to 39 weeks for women undergoing an induction of labor, and with possible differences in mode of delivery (all these parameters being associated to mid-term child's health).
2/ For the informed decision making for the women who reach 39 weeks gestation (i.e. the large majority of the pregnant women). Only mid-term data in early childhood after induction of labor for medical reason compared to expectant management are available; but they are obviously flawed by the indication that required the induction of labor (e.g. fetal growth restriction, premature of membranes, etc).
Thus, the first objective of the FAMILY-FA project is to evaluate the mid-term effect of elective induction of labor at 39 weeks of gestation compared with an expectant attitude in low-risk nulliparous women on child neurodevelopment at 5 years.
Similarly, mid-term follow-up of mothers enrolled in the FRENCH-ARRIVE trial with the assessment of obstetrical issues in case of future pregnancy, and maternal mental health, through the FAMILY-FA project, is essential:
332 studies on the registry are indexed under Neurodevelopmental Disorders; 143 are open to participants now.
This study's planned enrollment of 4,200 is above the median of 90 across 206 interventional studies indexed under Neurodevelopmental Disorders.
Browse Neurodevelopmental Disorders studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
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Inclusion Criteria:
Women randomized in the FRENCH-ARRIVE trial (NCT04799912):
Exclusion Criteria:
Exclusion criteria of the FRENCH-ARRIVE trial:
Moreover: the following postnatal criteria will be also exclusion criteria:
elective induction
Behavioral: Questionnaires
expectant management
Behavioral: Questionnaires
self-administered parental and teacher questionnaires 5 years after the birth of the first child (i.e., 5 years after enrollment in the FRENCH-ARRIVE trial). In addition, for a randomly selected subsample of 12% of participants (n=500), a brief neuropsychological assessment of their child (\~1 hour) will be conducted remotely via videoconference by a trained neuropsychologist
pediatric neurodevelopment at 5 years of age
pediatric neurodevelopment at 5 years of age, based on the assessment of different dimensions (development, motor, coordination, neurosensory, language, and behavior and executive functions). The Ages and Stages Questionnaire (ASQ-3) and the preschool version of the Child Behavior Checklist (CBCL 1½-5). The scales will be analyzed quantitatively, and the extreme values of the scores obtained will be considered pathological (≥2SD below mean or \<83th percentile, depending on the scale) according to the literature
Time frame: 5 years old
Child neurodevelopment
Neurodevelopment at 5 years of age, based on the Global School Adaptation score (GSA score) which has been shown to have a good correlation to cognitive abilities (see below) (4): Six questions investigate linguistic competence and 5 questions investigate non-verbal abilities. Eight questions address children's behavior in the classroom. The final question invites the teacher to give his or her prognosis for the child's future adaptation to school life. A score over 45 was defined as a positive evaluation of the child's adaptation to school life.
Time frame: 5 years old
Child cognition
Cognition (intellectual ability), evaluated using the WPPSI-IV (Wechsler Preschool \& Primary Scale of Intelligence), which measures cognitive ability in five domains (verbal comprehension, visuospatial indices, fluid reasoning, working memory, processing speed) resulting in a composite full scale intelligence quotient reflecting the overall level of intelligence. The test will be based on an online neuropsychological assessment for a random sample of 12% (N=500) of mother included in the FRENCH-ARRIVE trial
Time frame: 5 years old
Maternal depression
Maternal mental health including depression evaluated using the Beck Depression Inventory (BDI-II), a 21-item self-reported rating inventory that measures attitudes and symptoms of depression and screens for self-harm. The BDI-II score ranges from 0 to 63. A score of 0 to 13 suggests minimal depression; 14 to 19, mild depression; 20 to 28, moderate depression; and 29 to 63, severe depression
Time frame: Baseline
Maternal anxiety
Maternal mental health including anxiety evaluated using the 7-item Generalized Anxiety Disorder Questionnaire (GAD-7) measuring anxiety severity and which contains 7 items scored on a 0- to 3-point scale, with higher scores indicating worse anxiety. The GAD-7 has been validated in postpartum samples. A difference of 4 points defined a clinically significant change
Time frame: Baseline
Maternal partner relationship satisfaction
Partner relationship satisfaction assessed via maternal report on the 5-item short version Relationship Satisfaction Scale (RSS). Items were rated on a 6-point scale to reflect relationship satisfaction (eg, "I am very happy with our relationship") and partner relationship quality (eg, "my partner is generally understanding"). The scale consists of 10 statements to be answered on a 6-point scale from 1-strongly disagree to 6-strongly agree. Total scores range from 10 to 60, with lower scores indicating less satisfaction with the relationship.
Time frame: Baseline
Maternal precarity
Precarity, assessed using the EPICES score (Evaluation de la Précarité et des Inégalités de santé dans les Centres d'Examens de Santé), an individual indicator of precarity that takes into account the multidimensional nature of precarity. The score is continuous, ranging from 0 (no precarity) to 100 (maximum precarity). The threshold of 30 is considered to be the precarity threshold according to EPICES working group.
Time frame: Baseline
Maternal life questionnaire
Life questionnaire, assessed using simple questions asking the patient about her family status (e.g. "Are you in a relationship?"; "Are you in a relationship with the co-parent of your first child?"), and previous psychiatric history (e.g. "Have you ever consulted a psychiatrist ?"; "Have you ever consulted a psychologist?"; "Did you experience depression the year after the birth of your first child?"; "Have you ever taken psychotropic drugs?"). These simple questions are essential to gather information on any psychosocial comorbidities that may be confounding factors in the assessment of the child at age 5
Time frame: Baseline
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux