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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date  ICMJE June 9, 2015
First Posted Date  ICMJE July 1, 2015
Last Update Posted Date July 1, 2015
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2015)
Hemoglobin before delivery [ Time Frame: up to 32 weeks ]
anemia prevalence at delivery
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2015)
  • Birthweight [ Time Frame: measured once at birth ]
    birthweight at term
  • Gestatonal age at birth [ Time Frame: measured once at birth ]
    percentage of preterm delivies in each arm
  • Discontinuation of iron or mulimineral supplementation [ Time Frame: delivery ]
    discontinuation rate in every arm
  • Ferritin before delivery [ Time Frame: up to 32 weeks ]
    body iron stores at delivery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Different Iron Supplements for Prevention of Anemia in Pregnancy
Official Title  ICMJE Effektivität Der in Der Schwangerschaftsvorsorge routinemässig Angewandten Eisenprophylaxe
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Iron-Deficiency Anemia
  • Pregnancy
Intervention  ICMJE Drug: Iron sulfate and Iron polymaltose for prevention of iron deficiency anemia
Other Names:
  • gynotardiferon
  • maltofer
  • elevit
Study Arms  ICMJE
  • 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

    Intervention: Drug: Iron sulfate and Iron polymaltose for prevention of iron deficiency anemia
  • 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

    Intervention: Drug: Iron sulfate and Iron polymaltose for prevention of iron deficiency anemia
  • 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

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 30, 2015)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2016
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02487719
Other Study ID Numbers  ICMJE 2012-0475
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexander Krafft, MD University Hospital Zurich, Div. of Obstetrics
PRS Account University of Zurich
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP