Neurodevelopmental DisordersFAMILY-FANCT07330336
5-Year Follow-up of Children and Mother After Expectant Management Versus Induction of Labor in Low-risk Nulliparous Women at 39 Weeks of Gestation
A study testing Questionnaires in people with Neurodevelopmental Disorders, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Neurodevelopmental Disorders
- What is being tested?
- Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,200 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2026to Sep 2032
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women randomized in the FRENCH-ARRIVE trial (NCT04799912):
- Age ≥ 18 years
- Nulliparous women (i.e. no previous pregnancy beyond 20 weeks)
- With singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age.
- Gestational age at randomization between 37 weeks of gestation 0 day and 38 weeks of gestation 6 days inclusive based on the crown rump length measured at the first trimester ultrasound before 14 weeks of gestation and 0 days, as recommended in France
- Affiliated or beneficiary to a health security system
- Signed informed consent
- Non-opposition from both holders of parental authority to participation in the FAMILY-FA study
Who cannot join
- Project gestational age at date of first ultrasound is > 14 weeks
- Plan for induction of labor prior to 40 weeks 5 days
- Plan for cesarean delivery or contraindication to labor
- Breech presentation
- Multiple pregnancy
- Signs of labor (regular painful contractions with cervical change)
Show all 27Show fewer
- Fetal demise or known major fetal anomaly
- Heparin or low-molecular weight heparin during the current pregnancy
- Placenta previa, accreta, vasa previa
- Active vaginal bleeding greater than bloody show
- Ruptured membranes
- Cerclage in current pregnancy
- Known oligohydramnios, defined as Amniotic Fluid Index < 5 or Maximal Vertical Pocket < 2 cm
- Fetal growth restriction, defined as Estimated Fetal Weight < 10th percentile according to local curve
- Known HIV positivity because of modified delivery plan
- Major maternal medical illness associated with increased risk for adverse pregnancy outcome (for example, any diabetes mellitus, lupus, any hypertensive disorder, cardiac disease, renal insufficiency)
- Refusal of blood products
- Participation in another interventional study that may influence management of labor or delivery (labor induction, operative vaginal delivery, cesarean section, shoulder dystocia)
- Delivery planned elsewhere at a non-Network site
- History of myomectomy by laparotomy or laparoscopy
- Previous metroplasty for uterine malformation or Asherman syndrome
- Patient under legal protection
- Poor understanding of the French language
- Moreover: the following postnatal criteria will be also exclusion criteria:
- Major malformations and/or chromosomal aberrations evidenced in the child after birth
- Parents' refusal to participate in the follow-up
- Impossibility to contact the family
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
CHU Bordeaux
Bordeaux
Loïc Senilhes, MD, PhD, +33 5 56 79 55 79, loic.sentilhes@chu-bordeaux.fr
About this study
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
Read the detailed description
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:
- No comparative data are available on the obstetrical issues including mode of delivery in case of a subsequent pregnancy (the possible reduction of cesarean associated to the elective induction of labor at 39 weeks compared to an expectant management might be associated to a lower rate of cesarean and maternal and neonatal morbidity in a subsequent pregnancy).
- We have recently shown that induction of labor for medical reason was associated with impairment of maternal mental health in postpartum
- By assessing the maternal mental health as well as the other components of the life of the women (single or not, subsequent pregnancy or not) concomitantly to assessing the offspring development will allow us to taking into account potential cofounders associated to pediatric neurodevelopment (primary objective of our project). In fact, high quality evidence show that impaired maternal mental health affects intra-familial relationships and may impair the child's development.
- Conditions
- Neurodevelopmental Disorders
- Being tested
- Questionnaires
- Keywords
- Child neurodevelopmental disorder, pregnancy, Low-risk nulliparous women, induction of labor, elective, cesarean delivery, maternal mental health, postpartum, depression
- Medical subject headings
- Neurodevelopmental Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| elective induction arm | Experimental | elective induction Receives: Behavioral: Questionnaires |
| expectant management arm | Active comparator | expectant management Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years old
Secondary outcomes (7)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study startApr 2026 (estimated)
- Primary completionSep 2032 (estimated)
- Study completionSep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330336
- Sponsor's protocol ID
- CHUBX 2024/46
- Acronym
- FAMILY-FA
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5-Year Follow-up of Children and Mother After Expectant Management Versus Induction of Labor in Low-risk Nulliparous Women at 39 Weeks of Gestation
- ClinicalTrials.gov ID
- NCT07330336
- Acronym / sponsor ID
- FAMILY-FA / CHUBX 2024/46
- Conditions
- Neurodevelopmental Disorders
- Keywords
- Child neurodevelopmental disorder, pregnancy, Low-risk nulliparous women, induction of labor, elective, cesarean delivery, maternal mental health, postpartum
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,200 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Apr 2026 (estimated)
- Primary completion
- Sep 2032 (estimated)
- Study completion
- Sep 2032 (estimated)
- First posted
- 9 Jan 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.
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
Detailed description
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:
- No comparative data are available on the obstetrical issues including mode of delivery in case of a subsequent pregnancy (the possible reduction of cesarean associated to the elective induction of labor at 39 weeks compared to an expectant management might be associated to a lower rate of cesarean and maternal and neonatal morbidity in a subsequent pregnancy).
- We have recently shown that induction of labor for medical reason was associated with impairment of maternal mental health in postpartum
- By assessing the maternal mental health as well as the other components of the life of the women (single or not, subsequent pregnancy or not) concomitantly to assessing the offspring development will allow us to taking into account potential cofounders associated to pediatric neurodevelopment (primary objective of our project). In fact, high quality evidence show that impaired maternal mental health affects intra-familial relationships and may impair the child's development.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| elective induction arm | Experimental | Behavioral: Questionnaireselective induction |
| expectant management arm | Active comparator | Behavioral: Questionnairesexpectant management |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Women randomized in the FRENCH-ARRIVE trial (NCT04799912):
- Non-opposition from both holders of parental authority to participation in the FAMILY-FA study
Key exclusion criteria (27 listed)
- Moreover: the following postnatal criteria will be also exclusion criteria:
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 |
|---|---|---|
| Questionnairesself-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 | Behavioural | elective induction arm, expectant management arm |
Primary outcome
pediatric neurodevelopment at 5 years of age
Time frame: 5 years old
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
7 secondary outcomes
Child neurodevelopment
Time frame: 5 years old
Child cognition
Time frame: 5 years old
Maternal depression
Time frame: Baseline
Maternal anxiety
Time frame: Baseline
Maternal partner relationship satisfaction
Time frame: Baseline
Maternal precarity
Time frame: Baseline
Maternal life questionnaire
Time frame: Baseline
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 Jan 2026.
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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 Questionnaires in people with Neurodevelopmental Disorders, run by University Hospital, Bordeaux 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 8 inclusion and 27 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: opening soon, as of the sponsor's last update on 9 Jan 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 Loïc Sentilhes, MD, PhD (+33 5 56 79 55 79, loic.sentilhes@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pediatric neurodevelopment at 5 years of age (time frame: 5 years old). 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 Jan 2026.