Antenatal Detection of Fetal Growth Restriction and Stillbirths Rate.

NCT01995968 | Unknown

• 1 other identifier: DCIC12 08
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 21

Brief 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.

Conditions

Stillbirth; Intrauterine Growth Retardation; Infant, Small for Gestational Age

Keywords

Stillbirth; Fetal growth restriction; Small for gestational age; Antenatal detection; Prenatal Care; Mass Screening

Outcome Measures

Primary Outcomes (1)

• Rate of antenatal detection of FGR

  Crude and adjusted OR of stillbirth according to antenatal detection of FGR

  baseline

Secondary Outcomes (2)

• Factors associated with lack of antenatal detection of FGR in a representative sample of SGA births

  baseline

• fetal deaths of SGA newborns with and without antenatal detection of FGR

  baseline

Study Arms (2)

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

Other: Antenatal identification of fetal growth restriction

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

Other: Antenatal identification of fetal growth restriction

Interventions

Antenatal identification of fetal growth restriction OTHER

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

Also known as: Antenatal detection, Antenatal recognition, Antenatal suspicion

SGA livebirths (Controls); SGA stillbirths (Cases)

Eligibility Criteria

• Age: 24 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• Fetal deaths with date of death estimated being older than date of birth by at least 1 week
• Lethal congenital anomalies

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Registre de Handicap de l'Enfant et Observatoire Périnatal (RHEOP) Isère, Savoie et Haute-Savoie: collaborator
• UMRS 953, Epidemiological Research Unit on Perinatal and Women's and Children's Health, INSERM: collaborator

Study Sites (21)

CH Albertville-Moutiers

Albertville, 73200, France

Location

Clinique Générale Annecy

Annecy, 74000, France

Location

CH Annecy

Annecy, 74374, France

Location

Polyclinique de Savoie Annemasse

Annemasse, 74100, France

Location

CHI Annemasse Bonneville

Bonneville, 74107, France

Location

CH Bourg Saint Maurice

Bourg-Saint-Maurice, 73704, France

Location

Centre Hospitalier Bourgoin Jallieu

Bourgoin, 38300, France

Location

Clinique Saint Vincent de Paul Bourgoin Jallieu

Bourgoin, 38300, France

Location

Hopital Femme Mere Enfant

Bron, 69677, France

Location

CH Chambéry

Chambéry, 73000, France

Location

Clinique des Cèdres

Échirolles, 38432, France

Location

Chu Grenoble

Grenoble, 38000, France

Location

Clinique Mutualiste Eaux Claires

Grenoble, 38000, France

Location

Hopital Croix rousse

Lyon, 69317, France

Location

Clinique Belledonne

Saint Martin D Hères, 38400, France

Location

CH Saint Jean de Maurienne

Saint-Jean-de-Maurienne, 73303, France

Location

CH Sud Léman Valserine

Saint-Julien-en-Genevois, 74164, France

Location

Hôpitaux du Mont Blanc

Sallanches, 74700, France

Location

Hôpitaux du Léman

Thonon-les-Bains, 74203, France

Location

Centre Hospitalier Vienne

Vienne, 38209, France

Location

Centre Hospitalier Voiron

Voiron, 38506, France

Location

Related Publications (20)

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 18843617 BACKGROUND

• Neilson JP AZ. Doppler ultrasound for fetal assessment in high risk pregnancies (Cochrane review). The Cochrane Library, Issue 1, Oxford:Update software, 2002.

  BACKGROUND

• 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.

  PMID: 12504932 BACKGROUND

• 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.

  PMID: 15302194 BACKGROUND

• 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.

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• 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.

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MeSH Terms

Conditions

Stillbirth; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders

Study Officials

• Anne Ego, MD PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

• Christine CANS, MD PHD

  Registre Handicaps de l'Enfant et Observatoire Périnatal

  STUDY CHAIR

• Jennifer Zeitlin, MD PHD

  INSERM U953

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: November 27, 2013
• Study Start: November 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 4, 2015

Record last verified: 2014-12

Locations

FR (21)