Overview

This trial is active, not recruiting.

Conditions stillbirth, intrauterine growth retardation, infant, small for gestational age
Treatment antenatal identification of fetal growth restriction
Sponsor University Hospital, Grenoble
Collaborator Registre de Handicap de l’Enfant et Observatoire Périnatal (RHEOP) Isère, Savoie et Haute-Savoie
Start date November 2013
End date July 2015
Trial size 480 participants
Trial identifier NCT01995968, DCIC12 08

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
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
antenatal identification of fetal growth restriction Antenatal detection
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
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
antenatal identification of fetal growth restriction Antenatal detection
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

Primary Outcomes

Measure
Rate of antenatal detection of FGR
time frame: baseline

Secondary Outcomes

Measure
Factors associated with lack of antenatal detection of FGR in a representative sample of SGA births
time frame: baseline
fetal deaths of SGA newborns with and without antenatal detection of FGR
time frame: baseline

Eligibility Criteria

Male or female participants from 24 weeks up to 42 weeks old.

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

Additional Information

Official title Antenatal Detection of Fetal Growth Restriction : Determinants and Consequences for Stillbirths Rate.
Principal investigator Anne Ego, MD PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by University Hospital, Grenoble.