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Antenatal Detection of Fetal Growth Restriction and Stillbirths Rate.

NCT01995968 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 480

Last updated 2015-08-04

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Registre de Handicap de l'Enfant et Observatoire Périnatal (RHEOP) Isère, Savoie et Haute-Savoie

    collaborator UNKNOWN

  • UMRS 953, Epidemiological Research Unit on Perinatal and Women's and Children's Health, INSERM

    collaborator UNKNOWN

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Anne Ego, MD PhD · University Hospital, Grenoble

  • Christine CANS, MD PHD · Registre Handicaps de l'Enfant et Observatoire Périnatal

  • Jennifer Zeitlin, MD PHD · INSERM U953

Eligibility

Min Age
24 Weeks
Max Age
42 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-07-31
Completion
2015-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01995968 on ClinicalTrials.gov