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

31. juli 2015 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

480

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

5 måneder til 9 måneder (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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
Andre navne:
  • 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
Andre navne:
  • Antenatal detection
  • Antenatal recognition
  • Antenatal suspicion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of antenatal detection of FGR
Tidsramme: baseline
Crude and adjusted OR of stillbirth according to antenatal detection of FGR
baseline

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2013

Primær færdiggørelse (Faktiske)

1. juli 2015

Studieafslutning (Forventet)

1. december 2015

Datoer for studieregistrering

Først indsendt

8. november 2013

Først indsendt, der opfyldte QC-kriterier

26. november 2013

Først opslået (Skøn)

27. november 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. august 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. juli 2015

Sidst verificeret

1. december 2014

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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