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临床试验/NCT02487719
NCT02487719Unknown4 期

Effektivität Der in Der Schwangerschaftsvorsorge routinemässig Angewandten Eisenprophylaxe

University of Zurich1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
150
试验地点
1
主要终点
Hemoglobin before delivery

研究概览

简要总结

Examination of iron supplements routinely used in pregnancy to compare these with one another regarding effectiveness in the prevention of iron deficiency.

Determination of ferritin / hemoglobin every pregnant woman under the first routine check. Classification into one of three subgroups (group 1: iron sulfate, Group 2: iron polymaltose, Group 3: multivitamin- multimineral) depending on the measured values. Repetition of hemoglobin every 8 weeks, at the entrance to birth and postpartum day 1, additional provision of ferritin at the entrance to birth. In addition, registration of each child's birth weight and gestational age.

详细描述

Worldwide, iron deficiency is the most common shortage in women of childbearing age and also the most common cause of anemia. The prevalence of iron deficiency in young not pregnant women is 10-30%. During pregnancy take Frequency and importance of iron deficiency. Through organic growth and development of fetoplacental Unit and by maternal tissue formation, uterus growth and strong Expansion of maternal blood volume increases the pregnant woman the iron requirement for a Multiple. Starting from a non-pregnant state in the daily requirement of about 1 mg increasing this to 4-5 mg. Even with optimum food selection and a secured Increase of intestinal absorption in pregnancy, there is a negative Iron balance. The consequences are a depletion of iron stores (Serum ferritin <15 mcg / L) and a qualitative and quantitative disturbance of maternal Erythropoiesis with increased hypochromic and microcytic erythrocytes up to the occurrence anemia. The increased iron requirement is the background to a general recommendation an iron prophylaxis during pregnancy. However, this is possible due Reinforcement of gastrointestinal symptoms usually only from the 12th week of pregnancy is recommended. All pregnant women receive from the 12th week of pregnancy a multivitamin supplementation for the most important trace elements and vitamins. According to the guidelines of the Department of Obstetrics of USZ should a pregnant woman after the 12th week of pregnancy at a marginal ferritin <50mcg / l prophylactically receive additional iron and so anemia can be prevented. The aim of the study is on the one hand today's conventional iron supplements Maltofer Fol and Gyno-Tardyferon to examine their effectiveness, in particular with regard to the difference between two- and trivalent iron. On the other hand are at the usual multivitamin supplements. Women with normal iron stores at the beginning with respect to their effectiveness in preventing a depletion of these stores will be examined. Another aspect to be examined the occurrence of manifest iron deficiency anemia among called iron prophylaxis.

According to ferrtin value at first pregancy check, patients are enrolled after informed consent.

ferritin >50 mcg/L means patient will be randomized in eiter iron sulfate or iron polymaltose group. Ferritin > 50 mcg/L means pt will reeive multivitamin - multimineral containing iron. At midpregancy ferritin value is routinely checked as well at entering delivery floor at term.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • age above 18 yrs, singelton rpegnancy, inclusion before 16 completed weeks of gestation

排除标准

  • multiple pregnancy, contraindication for oral iron supplements or mulltivitamin preparations
  • iron deficiency or other anemia
  • hemoglobinopatheis
  • clinically significant disorders, as renal insuffisciency, hepatic dysfunction, cardiovascular disease

研究组 & 干预措施

Iron sulfate

Active Comparator

Iron sulfate (or) is given if randomly asigned in this group and Ferritin at inclusion < 50 mcg/L.

intervention: oral iron sulfate 1 tbl daily until birth

干预措施: Iron sulfate and Iron polymaltose for prevention of iron deficiency anemia (Drug)

Iron polymaltose

Active Comparator

Iron polymaltose (or) is given if randomly asigned in this group and Ferritin at inclusion < 50 mcg/L.

intervention: oral iron polymaltose 1 tbl daily until birth

干预措施: Iron sulfate and Iron polymaltose for prevention of iron deficiency anemia (Drug)

结局指标

主要结局

Hemoglobin before delivery

时间窗: up to 32 weeks

anemia prevalence at delivery

次要结局

  • Birthweight(measured once at birth)
  • Gestatonal age at birth(measured once at birth)
  • Ferritin before delivery(up to 32 weeks)
  • Discontinuation of iron or mulimineral supplementation(delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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