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Different Iron Supplements for Prevention of Anemia in Pregnancy (EDISA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02487719
Recruitment Status : Unknown
Verified June 2015 by University of Zurich.
Recruitment status was:  Recruiting
First Posted : July 1, 2015
Last Update Posted : July 1, 2015
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Iron-Deficiency Anemia Pregnancy Drug: Iron sulfate and Iron polymaltose for prevention of iron deficiency anemia Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effektivität Der in Der Schwangerschaftsvorsorge routinemässig Angewandten Eisenprophylaxe
Study Start Date : June 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Active Comparator: Iron sulfate

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

Drug: Iron sulfate and Iron polymaltose for prevention of iron deficiency anemia
Other Names:
  • gynotardiferon
  • maltofer
  • elevit

Active Comparator: Iron polymaltose

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

Drug: Iron sulfate and Iron polymaltose for prevention of iron deficiency anemia
Other Names:
  • gynotardiferon
  • maltofer
  • elevit

No Intervention: Multimineral

Routine supplementation of multivitamin. multimineral only. Ferritin level > 50 mcg/L at inclusion. No additional iron supplementation.

oral multivitamin- multimineral preparation 1 tbl daily until birth as done in daily clinic routine

Primary Outcome Measures :
  1. Hemoglobin before delivery [ Time Frame: up to 32 weeks ]
    anemia prevalence at delivery

Secondary Outcome Measures :
  1. Birthweight [ Time Frame: measured once at birth ]
    birthweight at term

  2. Gestatonal age at birth [ Time Frame: measured once at birth ]
    percentage of preterm delivies in each arm

  3. Discontinuation of iron or mulimineral supplementation [ Time Frame: delivery ]
    discontinuation rate in every arm

  4. Ferritin before delivery [ Time Frame: up to 32 weeks ]
    body iron stores at delivery

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02487719

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Contact: Alexander Krafft, M.D +41442551111

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University Hospital Zurich, Dept of Obstetrics Recruiting
Zurich, ZH, Switzerland, 8091
Contact: ALexander Krafft, MD    +41442551111   
Contact: Michele Stahel, MD    +41442551111   
Sponsors and Collaborators
University of Zurich
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Principal Investigator: Alexander Krafft, MD University Hospital Zurich, Div. of Obstetrics

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Responsible Party: University of Zurich Identifier: NCT02487719    
Other Study ID Numbers: 2012-0475
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: July 1, 2015
Last Verified: June 2015
Keywords provided by University of Zurich:
Iron deficiecy
prenatal care
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Ferric Compounds
Trace Elements
Growth Substances
Physiological Effects of Drugs