Antenatal Detection of Fetal Growth Restriction : Determinants and Consequences for Stillbirths Rate.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stillbirth
- Sponsor
- University Hospital, Grenoble
- Enrollment
- 480
- Locations
- 21
- Primary Endpoint
- Rate of antenatal detection of FGR
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Rate of antenatal detection of FGR
Time Frame: baseline
Crude and adjusted OR of stillbirth according to antenatal detection of FGR
Secondary Outcomes
- fetal deaths of SGA newborns with and without antenatal detection of FGR(baseline)
- Factors associated with lack of antenatal detection of FGR in a representative sample of SGA births(baseline)