Antenatal Detection of Fetal Growth Restriction and Stillbirths Rate. (REPERE)
31 juli 2015 bijgewerkt door: 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.
Studie Overzicht
Toestand
Onbekend
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Verwacht)
480
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Albertville, Frankrijk, 73200
- CH Albertville-Moutiers
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Annecy, Frankrijk, 74374
- CH Annecy
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Annecy, Frankrijk, 74000
- Clinique Générale Annecy
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Annemasse, Frankrijk, 74100
- Polyclinique de Savoie Annemasse
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Bonneville, Frankrijk, 74107
- CHI Annemasse Bonneville
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Bourg Saint Maurice, Frankrijk, 73704
- CH Bourg Saint Maurice
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Bourgoin Jallieu, Frankrijk, 38300
- Clinique Saint Vincent de Paul Bourgoin Jallieu
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Bourgoin-Jallieu, Frankrijk, 38300
- Centre Hospitalier Bourgoin Jallieu
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Bron, Frankrijk, 69677
- Hopital Femme Mere Enfant
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Chambéry, Frankrijk, 73000
- CH Chambéry
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Echirolles, Frankrijk, 38432
- Clinique des Cèdres
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Grenoble, Frankrijk, 38000
- Chu Grenoble
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Grenoble, Frankrijk, 38000
- Clinique Mutualiste Eaux Claires
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Lyon, Frankrijk, 69317
- Hopital croix rousse
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Saint Martin d Hères, Frankrijk, 38400
- Clinique Belledonne
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Saint-Jean-de-Maurienne, Frankrijk, 73303
- CH Saint Jean de Maurienne
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Saint-Julien-en-Genevois, Frankrijk, 74164
- CH Sud Léman Valserine
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Sallanches, Frankrijk, 74700
- Hôpitaux du Mont Blanc
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Thonon-les-Bains, Frankrijk, 74203
- Hopitaux du Leman
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Vienne, Frankrijk, 38209
- Centre Hospitalier Vienne
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Voiron, Frankrijk, 38506
- Centre Hospitalier Voiron
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
5 maanden tot 9 maanden (Kind)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
SGA births to mothers residents in 3 French districts (Isère, Savoie and Haute-Savoie)
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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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
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FGR is considered as "identified" if:
Andere namen:
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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
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FGR is considered as "identified" if:
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Rate of antenatal detection of FGR
Tijdsspanne: baseline
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Crude and adjusted OR of stillbirth according to antenatal detection of FGR
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baseline
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Factors associated with lack of antenatal detection of FGR in a representative sample of SGA births
Tijdsspanne: baseline
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Crude and adjusted OR and 95% confidence intervals
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baseline
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fetal deaths of SGA newborns with and without antenatal detection of FGR
Tijdsspanne: baseline
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baseline
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Anne Ego, MD PhD, University Hospital, Grenoble
- Studie stoel: Christine CANS, MD PHD, Registre Handicaps de l'Enfant et Observatoire Périnatal
- Studie directeur: Jennifer Zeitlin, MD PHD, INSERM U953
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Bricker L, Neilson JP. Routine ultrasound in late pregnancy (after 24 weeks gestation). Cochrane Database Syst Rev. 2000;(2):CD001451. doi: 10.1002/14651858.CD001451.
- Bricker L, Neilson JP, Dowswell T. Routine ultrasound in late pregnancy (after 24 weeks' gestation). Cochrane Database Syst Rev. 2008 Oct 8;(4):CD001451. doi: 10.1002/14651858.CD001451.pub3.
- Thornton JG, Hornbuckle J, Vail A, Spiegelhalter DJ, Levene M; GRIT study group. Infant wellbeing at 2 years of age in the Growth Restriction Intervention Trial (GRIT): multicentred randomised controlled trial. Lancet. 2004 Aug 7-13;364(9433):513-20. doi: 10.1016/S0140-6736(04)16809-8.
- Altman DG, Hytten FE. Intrauterine growth retardation: let's be clear about it. Br J Obstet Gynaecol. 1989 Oct;96(10):1127-32. doi: 10.1111/j.1471-0528.1989.tb03185.x. No abstract available.
- Pardi G, Marconi AM, Cetin I. Placental-fetal interrelationship in IUGR fetuses--a review. Placenta. 2002 Apr;23 Suppl A:S136-41. doi: 10.1053/plac.2002.0802.
- Kaufmann P SI. Placental development. In: Polin RA FW, eds, editor. Fetal and neonatal physiology. Philadelphia: WB Saunders, 1998:59-70.
- Baschat AA. Pathophysiology of fetal growth restriction: implications for diagnosis and surveillance. Obstet Gynecol Surv. 2004 Aug;59(8):617-27. doi: 10.1097/01.ogx.0000133943.54530.76.
- Hecher K, Snijders R, Campbell S, Nicolaides K. Fetal venous, intracardiac, and arterial blood flow measurements in intrauterine growth retardation: relationship with fetal blood gases. Am J Obstet Gynecol. 1995 Jul;173(1):10-5. doi: 10.1016/0002-9378(95)90161-2.
- Severi FM, Bocchi C, Visentin A, Falco P, Cobellis L, Florio P, Zagonari S, Pilu G. Uterine and fetal cerebral Doppler predict the outcome of third-trimester small-for-gestational age fetuses with normal umbilical artery Doppler. Ultrasound Obstet Gynecol. 2002 Mar;19(3):225-8. doi: 10.1046/j.1469-0705.2002.00652.x.
- Haws RA, Yakoob MY, Soomro T, Menezes EV, Darmstadt GL, Bhutta ZA. Reducing stillbirths: screening and monitoring during pregnancy and labour. BMC Pregnancy Childbirth. 2009 May 7;9 Suppl 1(Suppl 1):S5. doi: 10.1186/1471-2393-9-S1-S5.
- Imdad A, Yakoob MY, Siddiqui S, Bhutta ZA. Screening and triage of intrauterine growth restriction (IUGR) in general population and high risk pregnancies: a systematic review with a focus on reduction of IUGR related stillbirths. BMC Public Health. 2011 Apr 13;11 Suppl 3(Suppl 3):S1. doi: 10.1186/1471-2458-11-S3-S1.
- Alfirevic Z, Neilson JP. Doppler ultrasonography in high-risk pregnancies: systematic review with meta-analysis. Am J Obstet Gynecol. 1995 May;172(5):1379-87. doi: 10.1016/0002-9378(95)90466-2.
- Neilson JP, Alfirevic Z. Doppler ultrasound for fetal assessment in high risk pregnancies. Cochrane Database Syst Rev. 2000;(2):CD000073. doi: 10.1002/14651858.CD000073.
- GRIT Study Group. A randomised trial of timed delivery for the compromised preterm fetus: short term outcomes and Bayesian interpretation. BJOG. 2003 Jan;110(1):27-32. doi: 10.1016/s1470-0328(02)02514-4.
- Bais JM, Eskes M, Pel M, Bonsel GJ, Bleker OP. Effectiveness of detection of intrauterine growth retardation by abdominal palpation as screening test in a low risk population: an observational study. Eur J Obstet Gynecol Reprod Biol. 2004 Oct 15;116(2):164-9. doi: 10.1016/j.ejogrb.2004.01.037.
- Jahn A, Razum O, Berle P. Routine screening for intrauterine growth retardation in Germany: low sensitivity and questionable benefit for diagnosed cases. Acta Obstet Gynecol Scand. 1998 Jul;77(6):643-8. doi: 10.1034/j.1600-0412.1998.770611.x.
- Mattioli KP, Sanderson M, Chauhan SP. Inadequate identification of small-for-gestational-age fetuses at an urban teaching hospital. Int J Gynaecol Obstet. 2010 May;109(2):140-3. doi: 10.1016/j.ijgo.2009.11.023. Epub 2010 Feb 2.
- Lindqvist PG, Molin J. Does antenatal identification of small-for-gestational age fetuses significantly improve their outcome? Ultrasound Obstet Gynecol. 2005 Mar;25(3):258-64. doi: 10.1002/uog.1806.
- Ogundipe EM, Wolfe CD, Seed P, Gamsu HR. Does the antenatal detection of small-for-gestational-age babies influence their two-year outcomes? Am J Perinatol. 2000;17(2):73-81. doi: 10.1055/s-2000-9273.
- Fretts RC, Boyd ME, Usher RH, Usher HA. The changing pattern of fetal death, 1961-1988. Obstet Gynecol. 1992 Jan;79(1):35-9.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 november 2013
Primaire voltooiing (Werkelijk)
1 juli 2015
Studie voltooiing (Verwacht)
1 december 2015
Studieregistratiedata
Eerst ingediend
8 november 2013
Eerst ingediend dat voldeed aan de QC-criteria
26 november 2013
Eerst geplaatst (Schatting)
27 november 2013
Updates van studierecords
Laatste update geplaatst (Schatting)
4 augustus 2015
Laatste update ingediend die voldeed aan QC-criteria
31 juli 2015
Laatst geverifieerd
1 december 2014
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- DCIC12 08
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .