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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Registre de Handicap de l’Enfant et Observatoire Périnatal (RHEOP) Isère, Savoie et Haute-Savoie
UMRS 953, Epidemiological Research Unit on Perinatal and Women's and Children's Health, INSERM
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01995968
First received: November 8, 2013
Last updated: July 31, 2015
Last verified: December 2014
  Purpose

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.

Condition Intervention
Stillbirth
Intrauterine Growth Retardation
Infant, Small for Gestational Age
Other: Antenatal identification of fetal growth restriction

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: Antenatal Detection of Fetal Growth Restriction : Determinants and Consequences for Stillbirths Rate.

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Rate of antenatal detection of FGR [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Crude and adjusted OR of stillbirth according to antenatal detection of FGR


Secondary Outcome Measures:
  • Factors associated with lack of antenatal detection of FGR in a representative sample of SGA births [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Crude and adjusted OR and 95% confidence intervals

  • fetal deaths of SGA newborns with and without antenatal detection of FGR [ Time Frame: baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: November 2013
Estimated Study Completion Date: December 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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 Names:
  • 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
Other: 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 Names:
  • Antenatal detection
  • Antenatal recognition
  • Antenatal suspicion

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   24 Weeks to 42 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01995968

Locations
France
CH Albertville-Moutiers
Albertville, France, 73200
CH Annecy
Annecy, France, 74374
Clinique Générale Annecy
Annecy, France, 74000
Polyclinique de Savoie Annemasse
Annemasse, France, 74100
CHI Annemasse Bonneville
Bonneville, France, 74107
CH Bourg Saint Maurice
Bourg Saint Maurice, France, 73704
Clinique Saint Vincent de Paul Bourgoin Jallieu
Bourgoin Jallieu, France, 38300
Centre Hospitalier Bourgoin Jallieu
Bourgoin-Jallieu, France, 38300
Hopital Femme Mere Enfant
Bron, France, 69677
CH Chambéry
Chambéry, France, 73000
Clinique des Cèdres
Echirolles, France, 38432
Chu Grenoble
Grenoble, France, 38000
Clinique Mutualiste Eaux Claires
Grenoble, France, 38000
Hopital Croix rousse
Lyon, France, 69317
Clinique Belledonne
Saint Martin d Hères, France, 38400
CH Saint Jean de Maurienne
Saint-Jean-de-Maurienne, France, 73303
CH Sud Léman Valserine
Saint-Julien-en-Genevois, France, 74164
Hôpitaux du Mont Blanc
Sallanches, France, 74700
Hôpitaux du Léman
Thonon-les-Bains, France, 74203
Centre Hospitalier Vienne
Vienne, France, 38209
Centre Hospitalier Voiron
Voiron, France, 38506
Sponsors and Collaborators
University Hospital, Grenoble
Registre de Handicap de l’Enfant et Observatoire Périnatal (RHEOP) Isère, Savoie et Haute-Savoie
UMRS 953, Epidemiological Research Unit on Perinatal and Women's and Children's Health, INSERM
Investigators
Principal Investigator: Anne Ego, MD PhD University Hospital, Grenoble
Study Chair: Christine CANS, MD PHD Registre Handicaps de l'Enfant et Observatoire Périnatal
Study Director: Jennifer Zeitlin, MD PHD INSERM U953
  More Information

Publications:
Kaufmann P SI. Placental development. In: Polin RA FW, eds, editor. Fetal and neonatal physiology. Philadelphia: WB Saunders, 1998:59-70.
Neilson JP AZ. Doppler ultrasound for fetal assessment in high risk pregnancies (Cochrane review). The Cochrane Library, Issue 1, Oxford:Update software, 2002.

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01995968     History of Changes
Other Study ID Numbers: DCIC12 08
Study First Received: November 8, 2013
Last Updated: July 31, 2015
Health Authority: France: The Commission nationale de l’informatique et des libertés

Keywords provided by University Hospital, Grenoble:
Stillbirth
Fetal growth restriction
Small for gestational age
Antenatal detection
Prenatal Care
Mass Screening

Additional relevant MeSH terms:
Fetal Growth Retardation
Fetal Diseases
Growth Disorders
Pathologic Processes
Pregnancy Complications

ClinicalTrials.gov processed this record on August 30, 2015