Antenatal Detection of Fetal Growth Restriction and Stillbirths Rate.
NCT ID: NCT01995968
Last Updated: 2015-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
480 participants
OBSERVATIONAL
2013-11-30
2015-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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
Antenatal identification of fetal growth restriction
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
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
Antenatal identification of fetal growth restriction
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
Interventions
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Antenatal identification of fetal growth restriction
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Lethal congenital anomalies
24 Weeks
42 Weeks
ALL
No
Sponsors
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Registre de Handicap de l'Enfant et Observatoire Périnatal (RHEOP) Isère, Savoie et Haute-Savoie
UNKNOWN
UMRS 953, Epidemiological Research Unit on Perinatal and Women's and Children's Health, INSERM
UNKNOWN
University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Anne Ego, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Christine CANS, MD PHD
Role: STUDY_CHAIR
Registre Handicaps de l'Enfant et Observatoire Périnatal
Jennifer Zeitlin, MD PHD
Role: STUDY_DIRECTOR
INSERM U953
Locations
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CH Albertville-Moutiers
Albertville, , France
Clinique Générale Annecy
Annecy, , France
CH Annecy
Annecy, , France
Polyclinique de Savoie Annemasse
Annemasse, , France
CHI Annemasse Bonneville
Bonneville, , France
CH Bourg Saint Maurice
Bourg-Saint-Maurice, , France
Centre Hospitalier Bourgoin Jallieu
Bourgoin, , France
Clinique Saint Vincent de Paul Bourgoin Jallieu
Bourgoin, , France
Hopital Femme Mere Enfant
Bron, , France
CH Chambéry
Chambéry, , France
Clinique des Cèdres
Échirolles, , France
Chu Grenoble
Grenoble, , France
Clinique Mutualiste Eaux Claires
Grenoble, , France
Hopital Croix rousse
Lyon, , France
Clinique Belledonne
Saint Martin D Hères, , France
CH Saint Jean de Maurienne
Saint-Jean-de-Maurienne, , France
CH Sud Léman Valserine
Saint-Julien-en-Genevois, , France
Hôpitaux du Mont Blanc
Sallanches, , France
Hôpitaux du Léman
Thonon-les-Bains, , France
Centre Hospitalier Vienne
Vienne, , France
Centre Hospitalier Voiron
Voiron, , France
Countries
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References
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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.
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.
Neilson JP AZ. Doppler ultrasound for fetal assessment in high risk pregnancies (Cochrane review). The Cochrane Library, Issue 1, Oxford:Update software, 2002.
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: 10.1046/j.1471-0528.2003.02014.x.
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.
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.
Other Identifiers
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DCIC12 08
Identifier Type: -
Identifier Source: org_study_id
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