An observational study in Stillbirth, Intrauterine Growth Retardation and Infant, Small for Gestational Age, sponsored by University Hospital, Grenoble. Status unknown at 21 sites in France. Open to participants aged 24 Weeks to 42 Weeks. Per ClinicalTrials.gov, last updated 2015-08-04.
Sponsored by University Hospital, Grenoble · Observational
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
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.
264 studies on the registry are indexed under Fetal Growth Retardation; 66 are open to participants now.
This study's planned enrollment of 480 is above the median of 161 across 142 observational studies indexed under Fetal Growth Retardation.
Browse Fetal Growth Retardation studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
SGA births to mothers residents in 3 French districts (Isère, Savoie and Haute-Savoie)
Births:
Exclusion Criteria:
Stillbirths, SGA births (below the 10th percentile of French customised birthweight curves), born in 2012-13, at or after 24 completed weeks of gestational age, without lethal congenital anomalies, to mothers residents in Isère, Savoie or Haute-Savoie
Other: Antenatal identification of fetal growth restriction
Livebirths, SGA births (below the 10th percentile of French customised birthweight curves), born in 2013, at or after 24 completed weeks of gestational age, without lethal congenital anomalies, to mothers residents in Isère, Savoie or Haute-Savoie
Other: Antenatal identification of fetal growth restriction
FGR is considered as "identified" if: * FGR was mentioned in medical charts * OR at least one ultrasound fetometry had indicated an estimated fetal weight or an abdominal diameter below the 10th percentile (whatever the reference curve used) * OR no (or insufficient) weight gain between two ultrasounds mentioned in medical charts * OR pathological Doppler examination of the umbilical artery (absent or reversed blood flow at the end of diastole) * OR utero-placental Doppler ultrasound indicated for suspicion of growth failure
Also known as: Antenatal detection, Antenatal recognition, Antenatal suspicion
Rate of antenatal detection of FGR
Crude and adjusted OR of stillbirth according to antenatal detection of FGR
Time frame: baseline
Factors associated with lack of antenatal detection of FGR in a representative sample of SGA births
Crude and adjusted OR and 95% confidence intervals
Time frame: baseline
fetal deaths of SGA newborns with and without antenatal detection of FGR
Time frame: baseline
This study is status unknown, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble