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

2015年7月31日 更新者: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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (预期的)

480

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

5个月 至 9个月 (孩子)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

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

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
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

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
其他名称:
  • 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

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
其他名称:
  • Antenatal detection
  • Antenatal recognition
  • Antenatal suspicion

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Rate of antenatal detection of FGR
大体时间:baseline
Crude and adjusted OR of stillbirth according to antenatal detection of FGR
baseline

次要结果测量

结果测量
措施说明
大体时间
Factors associated with lack of antenatal detection of FGR in a representative sample of SGA births
大体时间:baseline
Crude and adjusted OR and 95% confidence intervals
baseline
fetal deaths of SGA newborns with and without antenatal detection of FGR
大体时间:baseline
baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Anne Ego, MD PhD、University Hospital, Grenoble
  • 学习椅:Christine CANS, MD PHD、Registre Handicaps de l'Enfant et Observatoire Périnatal
  • 研究主任:Jennifer Zeitlin, MD PHD、INSERM U953

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年11月1日

初级完成 (实际的)

2015年7月1日

研究完成 (预期的)

2015年12月1日

研究注册日期

首次提交

2013年11月8日

首先提交符合 QC 标准的

2013年11月26日

首次发布 (估计)

2013年11月27日

研究记录更新

最后更新发布 (估计)

2015年8月4日

上次提交的符合 QC 标准的更新

2015年7月31日

最后验证

2014年12月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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