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Iron Metabolism Parameters At First Trimester and preGnancy outcomE (IMAGE)

2017年6月1日 更新者:University Hospital, Clermont-Ferrand

Clinical and Biological Predictive Factors of Iron Deficiency Anemia in the Third Trimester of Pregnancy

Iron deficiency anemia is the leading cause of anemia during pregnancy, which can still reach 10 to 20% of pregnant women in developed countries, with potentially serious consequences for the child. Systematic iron supplementation remains controversial.

This study aims to identify in the first trimester of pregnancy clinical and biological predictive factors for the occurrence of iron deficiency anemia in the third trimester of pregnancy.

研究概览

地位

未知

详细说明

Objectives: The main objective is to determine the prevalence of anemia (Hb ≤ 11 g / dl) in the third trimester of pregnancy (T3) and to identify the predictive factors in the first trimester (T1).

Type of study: Prospective monocentric cohort.

Experimental plan: Pregnant women are included during the ultrasound of T1. Written consent will be sought after delivery of the information notice. Hemoglobin, classical iron balance (ferritin, transferrin saturation coefficient) as well as other original parameters: hepcidin and the soluble transferrin receptor are assayed. Socioeconomic and clinical parameters likely to favor an iron deficiency are sought through validated questionnaires. Nutritional advice, combined with martial supplementation if necessary, is given according to a standardized management protocol resulting from the current international recommendations and validated by an internal committee. The prevalence of iron deficiency anemia is determined at T3 (after 34 SA). The predictive factors for this anemia will be sought according to the data collected in T1.

The 2012 WHO's recommendations are in favour of a systematic supplementation of pregnant women. Epidemiological studies show that the anaemia at the end of pregnancy increases the risk of severe anaemia in the postpartum hospital stay and the frequency of transfusions in the mother is multiplied by 9. The quality of life of the mother seems too altered by the anaemia with increased susceptibility to infections, cognitive and emotional disorders in the postpartum period and a decrease of capacity of work and performance. In the human new-born, the anaemia is associated with a risk of prematurity, low weight birth and especially a certain degree of later psycho-motor delay, or even perinatal mortality. Side effects of iron orally, it's cost, make debatable systematic supplementation as interventional studies have given contradictory results in terms of morbidity and mortality infant. In areas where the anaemia prevalence is very high, a systematic supplementation of pregnant by 60 mg of iron (with folic acid) is beneficial in children on clues of psycho-intellectual development at 12, 18 and 24 months while multiple supplementation in micronutrients (containing 30 mg of iron) is not effective. However, systematic supplementation in countries with high socioeconomic level did debate. An Australian study Interventional, controlled, randomized conducted at 430 women showed no efficacy on the intellectual development of children in 4 years, without changing the quality of life of the mother during pregnancy, the authors observing even an increase of abnormal behaviors of the children of the mothers in the Group supplemented iron. In another study, the rational is highly questionable, a treatment by Iron versus placebo was given to pregnant women not anaemic with a high haemoglobin (an average of 14 g/dl): the women who took iron had high blood pressure at the end of pregnancy more and their children had a lower birth for the term weight.

In a developed country such as the France, one can legitimately wonder about the potentially harmful effects of routine iron supplementation for a population of pregnant women mainly not anaemic. In Great Britain of the recently published recommendations are pronounced against a systematic supplementation of iron in pregnant women. Other European authors advocate focused on the rate of ferritin supplementation. However, we are lacking of studies allowing, from clinical criteria and biological precise, to better target pregnant women who could benefit from supplementation of iron in the first quarter.

研究类型

观察性的

注册 (预期的)

865

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

    • Auvergne
      • Clermont-Ferrand、Auvergne、法国、63003
        • CHU de Clermont-Ferrand

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

15年 至 50年 (孩子、成人)

接受健康志愿者

是的

有资格学习的性别

女性

取样方法

非概率样本

研究人群

The women were screened at the maternity clinic of the gynecology-obstetrics department of CHU Estaing in Clermont-Ferrand, France.

描述

Inclusion Criteria:

  • Pregnant women in the first trimester between 11SA and 13 SA + 6 days
  • A written agreement is needed

Exclusion Criteria:

  • Women who do not know enough about reading and writing French to answer questionnaires
  • Women under 15 at inclusion

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
Pregnant women
Pregnant women are included during the ultrasound of T1. Written consent will be sought after delivery of the information notice.
The prevalence of iron deficiency anemia is determined at T3 (after 34 SA). The predictive factors for this anemia will be sought according to the data collected in T1.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Hemoglobin value
大体时间:in the third trimestry of pregnancy
in the third trimestry of pregnancy

次要结果测量

结果测量
措施说明
大体时间
Rate of clinical and biological factors per patient
大体时间:at the first trimestry of pregnancy
demographics and clinical factors and biological factors (hepcidine, ferritine, RST)
at the first trimestry of pregnancy
Rate of demographics and clinical factors per patient
大体时间:at the first trimestry of pregnancy
biological factors (hepcidine, ferritine, RST)
at the first trimestry of pregnancy
Rate of biological factors per patient
大体时间:at the first trimestry of pregnancy
Such as : hepcidine, ferritine, RST
at the first trimestry of pregnancy

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:Marc RUIVARD, MD, PhD、CHU de Clermont-Ferrand

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 (实际的)

2015年11月12日

初级完成 (预期的)

2017年6月1日

研究完成 (预期的)

2018年1月1日

研究注册日期

首次提交

2017年5月30日

首先提交符合 QC 标准的

2017年6月1日

首次发布 (实际的)

2017年6月5日

研究记录更新

最后更新发布 (实际的)

2017年6月5日

上次提交的符合 QC 标准的更新

2017年6月1日

最后验证

2017年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • CHU-336
  • 2015-A00454-45 (其他标识符:2015-A00454-45)

药物和器械信息、研究文件

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研究美国 FDA 监管的设备产品

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