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临床试验/NCT04016922
NCT04016922Unknown不适用

Effect of Maternal Iron Deficiency Anemia on Fetal Hemodynamics and Neonatal Outcome

Cairo University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
1
主要终点
Changes in fetal vascular doppler parameters.

研究概览

简要总结

This study will be conducted to show the effect of different degrees of maternal iron deficiency anemia on fetal hemodynamics and neonatal outcome and to evaluate the effect of treatment.

详细描述

Hemoglobin concentration is used to determine the diagnosis and severity of anemia in low resource settings, an indicator that is routinely screened using WHO-defined hemoglobin cutoffs. These thresholds are lower for pregnant women (females ≥ 15 years of age) than non-pregnant women (11.0 g/dl versus 12.0 g/dl). Severity of anemia is determined using additional cutoffs, with severe anemia defined as a hemoglobin level of less than 7.0 g/dl.

Iron deficiency is defined as a condition in which there are no mobilizable iron stores, resulting from a long-term negative iron balance and leading to a compromised supply of iron to the tissues. Finally, the most significant negative consequence of ID is anemia, usually microcytic hypochromic in nature.

IDA has been linked to unfavorable outcomes of pregnancy. It is the most common nutritional disorder in the world affecting two billion people worldwide with pregnant women particularly at risk. According to WHO report, 2001 indicates that IDA is a significant problem throughout the world ranging from 35-75% in developing countries (average 56%) whereas in industrialized countries the average prevalence is 14%.

Distribution of blood flow (between the placental and cerebral regions) is determined with Middle cerebral artery PI/Umbilical artery PI (C/U ratio); this parameter is always > 1.1 during normal pregnancy, but decreases in the case of hypoxia because of umbilical artery resistance index increase (increase in placental resistance) and cerebral resistance index decrease (cerebral vasodilation).

Perinatal morbidity & mortality of IUGR infants is 3-20 times greater than normal infants. These cases may be followed with outpatient monitoring and they often deliver at term. However process is not severe enough to stop fetal growth completely or to deteriorate. The umbilical artery and the middle cerebral artery waveforms may be abnormal, without effect is seen on Doppler and growth until 26-32 weeks gestation; Mild utero-placental insufficiency.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant females aged 20- 35 years.
  • Gestational age 32 weeks or more.
  • Living singleton fetus.

排除标准

  • Multifetal pregnancy.
  • Patients with chronic illness or medical disorders other than iron deficiency anemia.
  • Patients with history of recurrent perinatal deaths or recent blood transfusion or other vitamin deficiency anemia.

结局指标

主要结局

Changes in fetal vascular doppler parameters.

时间窗: 4 months from June 2019 till October 2019

Fetal doppler parameters by resistance index and pulsatility index at first visit and 10 days after recieving treatment and at delivery.

Neonatal birth weight

时间窗: 4 months June 2019 till October 2019

Neonatal birth weight in kilograms

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mai Elsayed Amin

Assistant lecturer

Cairo University

研究点 (1)

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