Clinical trial NCT01995968: Antenatal Detection of Fetal Growth Restriction and Stillbirths Rate.
Official title: Antenatal Detection of Fetal Growth Restriction : Determinants and Consequences for Stillbirths Rate.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stillbirth
Intrauterine Growth Retardation
Infant, Small for Gestational Age
Keywords: Stillbirth
Fetal growth restriction
Small for gestational age
Antenatal detection
Prenatal Care
Mass Screening
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Registre de Handicap de l'Enfant et Observatoire Périnatal (RHEOP) Isère, Savoie et Haute-Savoie
name: UMRS 953, Epidemiological Research Unit on Perinatal and Women's and Children's Health, INSERM
First posted: 2013-11-27
Enrollment: 480
Sex: ALL
Minimum age (years): 24
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: SGA births to mothers residents in 3 French districts (Isère, Savoie and Haute-Savoie)

Brief summary: The main objective is to assess the role of antenatal detection of fetal growth restriction (FGR) on stillbirth, by a case-control study in a population-based sample of small for gestational age (SGA) livebirths and stillbirths in 3 French counties (Isère, Savoie and Haute-Savoie). SGA births will be defined as a birthweight below the 10th percentile of French customised birth weight curves.

Our secondary objectives are

* to identify determinants of antenatal detection of FGR among a representative sample of SGA births, with a special interest in the definition of FGR. Our hypothesis is that births who are SGA by customised birthweight curves and non-SGA by population birthweight curves, are not detected antenatally, despite the current strategy including the use of umbilical Doppler.
* to analyse prenatal care of a subsample of SGA stillbirths with and without detection of FGR by a confidential enquiry.

Detailed description: Stillbirths will be identified by the RHEOP (Registre des Handicaps de l'Enfant et Observatoire Périnatal).

The RHEOP was created in 1988 in the Isère district in the Rhône-Alpes region of France. The area covered by the registry was enlarged to include two contiguous districts in 2005 (Savoie and Haute-Savoie). This registry includes all cases of childhood disability as well as all stillbirths to residents in these districts. Its objective is to monitor the trends in stillbirth and chid disability, and to identify conditions associated with these events. The three participating districts constitute a population-based sample of 30 000 births per year. The RHEOP registry uses the WHO definition of a stillbirth, i.e., "the birth of a baby with a birth weight of 500 g or 22 or more completed weeks of gestation who died before or during labor and birth". Its completeness is checked by matching its database with three data sources : results of placental examination and fetal autopsy, adjacent register of fetal anomalies, and regional reference center for prenatal diagnosis.

Stillbirths are identified in maternity hospitals thanks to collaborating midwifes and routinely collected data. Several specific investigators, who are trained nurses, midwives or physicians, complete a standardized form based on the medical record for each case.

For the purpose of the project, additional data will be collected allowing to describe prenatal care including ultrasound and Doppler examinations, and obstetrical management. Healthcare professionals (GP, midwife, obstetricians and gynecologists) will be solicited if data are missing in maternity medical records. SGA stillbirths in 2012 and 2013 will be included.

Consecutive SGA livebirths to residents in Isère, Savoie and Haute-Savoie, will be identified by the same way. Two months (probably october and november 2013)are approximately needed to record the sample size of controls.

Eligibility criteria: Inclusion Criteria:

Births:

* Stillbirths (antepartum or intrapartum fetal death) (=Cases) or livebirths (=Controls)
* at or after 24 completed weeks of gestational age
* singletons
* to mothers residents in 1 of the 3 districts (Isère, Savoie, Haute-Savoie) of the RHEOP register
* SGA: birthweight below the 10th percentile of French customised birthweight curves)

Exclusion Criteria:

* Fetal deaths with date of death estimated being older than date of birth by at least 1 week
* Lethal congenital anomalies

Primary outcomes:
measure: Rate of antenatal detection of FGR
timeFrame: baseline
Secondary outcomes:
measure: Factors associated with lack of antenatal detection of FGR in a representative sample of SGA births
timeFrame: baseline
measure: fetal deaths of SGA newborns with and without antenatal detection of FGR
timeFrame: baseline
Other outcomes:
Locations:
city: Albertville
country: France
facility: CH Albertville-Moutiers
city: Annecy
country: France
facility: Clinique Générale Annecy
city: Annecy
country: France
facility: CH Annecy
city: Annemasse
country: France
facility: Polyclinique de Savoie Annemasse
city: Bonneville
country: France
facility: CHI Annemasse Bonneville
city: Bourg Saint Maurice
country: France
facility: CH Bourg Saint Maurice
city: Bourgoin Jallieu
country: France
facility: Clinique Saint Vincent de Paul Bourgoin Jallieu
city: Bourgoin-Jallieu
country: France
facility: Centre Hospitalier Bourgoin Jallieu
city: Bron
country: France
facility: Hopital Femme Mere Enfant
city: Chambéry
country: France
facility: CH Chambéry
city: Echirolles
country: France
facility: Clinique des Cèdres
city: Grenoble
country: France
facility: Chu Grenoble
city: Grenoble
country: France
facility: Clinique Mutualiste Eaux Claires
city: Lyon
country: France
facility: Hopital Croix rousse
city: Saint Martin d Hères
country: France
facility: Clinique Belledonne
city: Saint-Jean-de-Maurienne
country: France
facility: CH Saint Jean de Maurienne
city: Saint-Julien-en-Genevois
country: France
facility: CH Sud Léman Valserine
city: Sallanches
country: France
facility: Hôpitaux du Mont Blanc
city: Thonon-les-Bains
country: France
facility: Hôpitaux du Léman
city: Vienne
country: France
facility: Centre Hospitalier Vienne
city: Voiron
country: France
facility: Centre Hospitalier Voiron
Study officials:
affiliation: University Hospital, Grenoble
name: Anne Ego, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Registre Handicaps de l'Enfant et Observatoire Périnatal
name: Christine CANS, MD PHD
role: STUDY_CHAIR
affiliation: INSERM U953
name: Jennifer Zeitlin, MD PHD
role: STUDY_DIRECTOR
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