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临床试验/NCT03836703
NCT03836703已完成4 期

Doubling the Iron Dose VS Single Dose Iron Supplementation to Prevent Iron Deficiency Anemia (IDA) in Twin Pregnant Women: A Randomized Controlled Trial

Ain Shams University1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2019年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
450
试验地点
1
主要终点
Hemoglobin level below 11 g/dl

研究概览

简要总结

In twin pregnancies, the maternal iron demands are magnified, estimated at 1.8 times more than in singleton pregnancies due to greater maternal red blood cell mass and plasma volume expansion as well as increased fetal and placental requirements.

With a lack of randomized controlled trials assessing the adequacy of iron supplements on twin pregnancy, various recommendations are based on level 3 clinical expert opinions at most.

详细描述

Iron deficiency anemia (IDA) is a very prevalent condition in pregnancy, affecting nearly 18% of all pregnant women during all three trimesters, with as many as 29%of women affected during the third trimester.

In twin pregnancies, the maternal iron demands are magnified, estimated at 1.8 times more than in singleton pregnancies due to greater maternal red blood cell mass and plasma volume expansion as well as increased fetal and placental requirements. Thus, maternal hemoglobin (Hgb) in multiple pregnancies is lower in all trimesters compared with singleton gestations, with a rate of IDA estimated to be 2.4 to even 4 times higher.

Expert opinion relying on the increased risk for micronutrient deficiency in twin pregnancies recommends supplementation of iron beyond that contained in a typical prenatal vitamin. Moreover, some experts support doubling the dose of multivitamins containing 30 mg of elemental iron during the second and third trimesters of a twin pregnancy, regardless of maternal Hgb and ferritin concentrations.

With a lack of randomized controlled trials assessing the adequacy of iron supplements on twin pregnancy, various recommendations are based on level 3 clinical expert opinions at most. The purpose of our study was to assess the efficacy of a single versus a double daily iron supplement dose in iron deficient women with twin pregnancies. Determining the effect of this intervention on maternal iron stores and immediate neonatal outcome measures will assist in defining evidence based recommendations for prenatal care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Twin pregnancy.
  • Hemoglobin ≥ 10.5 gm/d l. at booking visit

排除标准

  • Continuous hyper-emesis gravid arum lasting beyond 20 weeks of gestation
  • Thalassemia minor (alpha or beta).
  • Mal-absorption disorders (such as inflammatory bowel diseases, Crohn's disease, ulcerative colitis, previous bowel resection).
  • Anemia from chronic illness.
  • Any use of multi-vitamin supplements containing iron.
  • Any chronic blood loss. e.g: hemorrhoids.
  • Autoimmune disorders.

研究组 & 干预措施

Single Dose Daily Iron

Active Comparator

single dose daily Iron'IRON FUM&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE supplementation From 14 weeks gestation to prevent iron deficiency anemia

干预措施: Feroglobin single daily use (Drug)

Double dose Daily iron

Experimental

Double dose daily Iron'IRON FUM&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE supplementation From 14 weeks gestation to prevent iron deficiency anemia

干预措施: Feroglobin twice daily dose (Drug)

结局指标

主要结局

Hemoglobin level below 11 g/dl

时间窗: 24 hours before delivery

incidence of Iron deficiency anemia

次要结局

  • Preterm Birth(delivery before 37 weeks gestation)
  • GIT side effects(all over the pregnancy time 14 weeks gestation to delivery)
  • neonatal Birth weidht(5 min. after delivery)
  • blood product administration(24 hours after delivery)

研究者

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

Ahmed Abass

Lecturer

Ain Shams University

研究点 (1)

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