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

July 31, 2015 updated by: 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

480

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 9 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of antenatal detection of FGR
Time Frame: baseline
Crude and adjusted OR of stillbirth according to antenatal detection of FGR
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors associated with lack of antenatal detection of FGR in a representative sample of SGA births
Time Frame: baseline
Crude and adjusted OR and 95% confidence intervals
baseline
fetal deaths of SGA newborns with and without antenatal detection of FGR
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

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

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

November 8, 2013

First Submitted That Met QC Criteria

November 26, 2013

First Posted (Estimate)

November 27, 2013

Study Record Updates

Last Update Posted (Estimate)

August 4, 2015

Last Update Submitted That Met QC Criteria

July 31, 2015

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC12 08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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