Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01995968
Study type Observational [Patient Registry]
Source University Hospital, Grenoble
Contact
Status Active, not recruiting
Phase N/A
Start date November 2013
Completion date December 2015

See also
  Status Clinical Trial Phase
Completed NCT01196156 - Follow-up to Adult Height of a Cohort of Subjects Born Small for the Gestational Age and Treated With Growth Hormone
Completed NCT02379728 - Ghana PrenaBelt Trial: A Positional Therapy Device to Reduce Still-Birth N/A
Completed NCT00114543 - Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight Phase 3
Completed NCT00011362 - Dexamethasone Therapy in VLBW Infants at Risk of CLD Phase 3
Completed NCT05217186 - Associations Between Early Neonatal Neuroimaging, Hammersmith Infant Neurological Examination and General Movements
Completed NCT03082313 - Movement-based Infant Intervention N/A
Completed NCT01193270 - Vitamin E for Extremely Preterm Infants Phase 1
Completed NCT01203423 - Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study
Completed NCT03726697 - Effect of Tahneek on Hypoglycemia in Newborn Infants N/A
Completed NCT01223287 - Physiologic Definition of Bronchopulmonary Dysplasia N/A
Active, not recruiting NCT05343403 - Parental Participation on the Neonatal Ward - the neoPARTNER Study
Withdrawn NCT04360967 - SURF, Neurodevelopment, Growth Study in SGA Infants N/A
Completed NCT01082354 - A Pharmaco-epidemiological Study of Short Patients Born Small for Gestational Age (SGA), Treated With Saizen® (Recombinant Somatropin) N/A
Completed NCT00109525 - Early Diagnosis of Candidiasis in Premature Infants
Completed NCT00067613 - Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia N/A
Completed NCT01223261 - Observational Study of Surgical Treatment of Necrotizing Enterocolotis
Recruiting NCT04367181 - DCS Study in Extremely Premature Newborns N/A
Completed NCT02377817 - Halifax PrenaBelt Trial N/A
Completed NCT00349726 - Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants Phase 2
Completed NCT01222364 - Delayed Cord Clamping in VLBW Infants Phase 1/Phase 2