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临床试验/NCT03565198
NCT03565198Unknown不适用

Serum Ferritin as a Predictor for Development of Anemia in Pregnancy: A Pilot Study

CAMC Health System1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年8月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
clinical anemia

研究概览

简要总结

Anemia is a common problem with pregnant women around the world. There are high rates even within industrialized nations. The main cause of anemia in pregnancy is a lack of iron. There have been medical programs that give iron vitamins to all pregnant patients at the beginning of care to decrease anemia. These programs did not adequately decrease anemia in pregnancy. Many of them gave iron vitamins in doses that were low because pregnant patients sometimes have side effects to it. The next idea was to figure out which women were more at risk to get anemia and then treat them with a higher amount of iron. There are different blood tests to see how much iron stores are in the blood, but many do not work well during pregnancy. The test study staff think is the best for this is ferritin. The goal of this first small study is to see if healthcare providers can use the level of ferritin to predict anemia in pregnancy. This would then help to better screen, diagnose, and treat anemia during pregnancy. Study staff will enroll obstetric patients from the Women's Medicine Center and compare ferritin levels in these patients early in pregnancy with diagnosis of anemia later in pregnancy.

详细描述

In the past, all pregnant patients were started on an iron supplement (in addition to that which is in prenatal vitamins), with the presumption that they had low or inadequate iron stores. That "habit" has gone by the wayside. Now, health care providers wait until a patient is already anemic and then start iron supplementation. In general, the first opportunity to determine if a patient is anemic as the pregnancy progresses comes at about 28 weeks of gestation when routine laboratory testing includes a Hemoglobin level. It is the author's hope that there is some middle ground.

d. Specific Aims/Objectives:

The aim of this study is to test if ferritin levels taken in early pregnancy can predict the development of iron deficiency anemia later in pregnancy.

Hypothesis: Serum ferritin levels, when tested prior to 20 weeks gestation, can identify women who will develop iron deficiency anemia before delivery.

e. Methods, Procedure, Sample

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
15 Years 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 15-45 years old at intake
  • Confirmed intrauterine pregnancy by 1st trimester ultrasound

排除标准

  • Antepartum iron supplementation, other than prenatal vitamins
  • Placental abruption or hemorrhage
  • Initial visit >20 weeks gestation
  • Diagnosis of sickle cell disease or thalassemia
  • Diagnosed with anemia at initial prenatal visit
  • Diagnosis of autoimmune issues that could effect iron levels

结局指标

主要结局

clinical anemia

时间窗: 28 weeks gestation

hemoglobin \< 11 mg/dL

次要结局

未报告次要终点

研究者

发起方
CAMC Health System
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul Dietz

PI

CAMC Health System

研究点 (1)

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