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

Effektivität Der in Der Schwangerschaftsvorsorge routinemässig Angewandten Eisenprophylaxe

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy; Iron-Deficiency Anemia
• Intervention / Treatment: Drug: Iron sulfate and Iron polymaltose for prevention of iron deficiency anemia

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: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • Recruiting
      • University Hospital Zurich, Dept of Obstetrics
      • Contact: ALexander Krafft, MD; Phone Number: +41442551111; Email: alexander.krafft@usz.ch
      • Contact: Michele Stahel, MD; Phone Number: +41442551111; Email: michele.stahel@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin before delivery	anemia prevalence at delivery	up to 32 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Birthweight	birthweight at term	measured once at birth
Gestatonal age at birth	percentage of preterm delivies in each arm	measured once at birth
Discontinuation of iron or mulimineral supplementation	discontinuation rate in every arm	delivery
Ferritin before delivery	body iron stores at delivery	up to 32 weeks

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Alexander Krafft, MD, University Hospital Zurich, Div. of Obstetrics

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: June 9, 2015
• First Submitted That Met QC Criteria: June 30, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Estimate): July 1, 2015
• Last Update Submitted That Met QC Criteria: June 30, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: pregnancy; prenatal care; Iron deficiecy
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia; Hematinics; Teferrol
• Other Study ID Numbers: 2012-0475