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

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ClinicalTrials.gov Identifier: NCT01995968
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Grenoble.
Recruitment status was:  Active, not recruiting
First Posted : November 27, 2013
Last Update Posted : August 4, 2015
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

Tracking Information
First Submitted Date November 8, 2013
First Posted Date November 27, 2013
Last Update Posted Date August 4, 2015
Study Start Date November 2013
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 26, 2013)
Rate of antenatal detection of FGR [ Time Frame: baseline ]
Crude and adjusted OR of stillbirth according to antenatal detection of FGR
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 26, 2013)
  • 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
  • fetal deaths of SGA newborns with and without antenatal detection of FGR [ Time Frame: baseline ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Antenatal Detection of Fetal Growth Restriction and Stillbirths Rate.
Official Title Antenatal Detection of Fetal Growth Restriction : Determinants and Consequences for Stillbirths Rate.
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.
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 [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 1 Week
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population SGA births to mothers residents in 3 French districts (Isère, Savoie and Haute-Savoie)
Condition
  • Stillbirth
  • Intrauterine Growth Retardation
  • Infant, Small for Gestational Age
Intervention 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
Study Groups/Cohorts
  • 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
    Intervention: 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
    Intervention: Other: Antenatal identification of fetal growth restriction
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 26, 2013)
480
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 24 Weeks to 42 Weeks   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01995968
Other Study ID Numbers DCIC12 08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Grenoble
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
PRS Account University Hospital, Grenoble
Verification Date December 2014