Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Antenatal Detection of Fetal Growth Restriction and Stillbirths Rate. (REPERE)

31 juli 2015 uppdaterad av: University Hospital, Grenoble

Antenatal Detection of Fetal Growth Restriction : Determinants and Consequences for Stillbirths Rate.

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

480

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Albertville, Frankrike, 73200
        • CH Albertville-Moutiers
      • Annecy, Frankrike, 74374
        • CH Annecy
      • Annecy, Frankrike, 74000
        • Clinique Générale Annecy
      • Annemasse, Frankrike, 74100
        • Polyclinique de Savoie Annemasse
      • Bonneville, Frankrike, 74107
        • CHI Annemasse Bonneville
      • Bourg Saint Maurice, Frankrike, 73704
        • CH Bourg Saint Maurice
      • Bourgoin Jallieu, Frankrike, 38300
        • Clinique Saint Vincent de Paul Bourgoin Jallieu
      • Bourgoin-Jallieu, Frankrike, 38300
        • Centre Hospitalier Bourgoin Jallieu
      • Bron, Frankrike, 69677
        • Hopital Femme Mere Enfant
      • Chambéry, Frankrike, 73000
        • CH Chambery
      • Echirolles, Frankrike, 38432
        • Clinique des Cèdres
      • Grenoble, Frankrike, 38000
        • CHU Grenoble
      • Grenoble, Frankrike, 38000
        • Clinique Mutualiste Eaux Claires
      • Lyon, Frankrike, 69317
        • Hopital Croix Rousse
      • Saint Martin d Hères, Frankrike, 38400
        • Clinique Belledonne
      • Saint-Jean-de-Maurienne, Frankrike, 73303
        • CH Saint Jean de Maurienne
      • Saint-Julien-en-Genevois, Frankrike, 74164
        • CH Sud Léman Valserine
      • Sallanches, Frankrike, 74700
        • Hôpitaux du Mont Blanc
      • Thonon-les-Bains, Frankrike, 74203
        • Hôpitaux du Léman
      • Vienne, Frankrike, 38209
        • Centre Hospitalier Vienne
      • Voiron, Frankrike, 38506
        • Centre Hospitalier Voiron

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

5 månader till 9 månader (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

SGA births to mothers residents in 3 French districts (Isère, Savoie and Haute-Savoie)

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
SGA stillbirths (Cases)
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

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
Andra namn:
  • Antenatal detection
  • Antenatal recognition
  • Antenatal suspicion
SGA livebirths (Controls)
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

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
Andra namn:
  • Antenatal detection
  • Antenatal recognition
  • Antenatal suspicion

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Rate of antenatal detection of FGR
Tidsram: baseline
Crude and adjusted OR of stillbirth according to antenatal detection of FGR
baseline

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Factors associated with lack of antenatal detection of FGR in a representative sample of SGA births
Tidsram: baseline
Crude and adjusted OR and 95% confidence intervals
baseline
fetal deaths of SGA newborns with and without antenatal detection of FGR
Tidsram: baseline
baseline

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Anne Ego, MD PhD, University Hospital, Grenoble
  • Studiestol: Christine CANS, MD PHD, Registre Handicaps de l'Enfant et Observatoire Périnatal
  • Studierektor: Jennifer Zeitlin, MD PHD, INSERM U953

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 november 2013

Primärt slutförande (Faktisk)

1 juli 2015

Avslutad studie (Förväntat)

1 december 2015

Studieregistreringsdatum

Först inskickad

8 november 2013

Först inskickad som uppfyllde QC-kriterierna

26 november 2013

Första postat (Uppskatta)

27 november 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

4 augusti 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 juli 2015

Senast verifierad

1 december 2014

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

3
Prenumerera