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

Primary Purpose

Iron-Deficiency Anemia, Pregnancy

Status
Unknown status
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Iron sulfate and Iron polymaltose for prevention of iron deficiency anemia
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron-Deficiency Anemia focused on measuring Iron deficiecy, pregnancy, prenatal care

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital Zurich, Dept of ObstetricsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Iron sulfate

Iron polymaltose

Multimineral

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Hemoglobin before delivery
anemia prevalence at delivery

Secondary Outcome Measures

Birthweight
birthweight at term
Gestatonal age at birth
percentage of preterm delivies in each arm
Discontinuation of iron or mulimineral supplementation
discontinuation rate in every arm
Ferritin before delivery
body iron stores at delivery

Full Information

First Posted
June 9, 2015
Last Updated
June 30, 2015
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT02487719
Brief Title
Different Iron Supplements for Prevention of Anemia in Pregnancy
Acronym
EDISA
Official Title
Effektivität Der in Der Schwangerschaftsvorsorge routinemässig Angewandten Eisenprophylaxe
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-Deficiency Anemia, Pregnancy
Keywords
Iron deficiecy, pregnancy, prenatal care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Iron sulfate
Arm Type
Active Comparator
Arm Description
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
Arm Title
Iron polymaltose
Arm Type
Active Comparator
Arm Description
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
Arm Title
Multimineral
Arm Type
No Intervention
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Iron sulfate and Iron polymaltose for prevention of iron deficiency anemia
Other Intervention Name(s)
gynotardiferon, maltofer, elevit
Primary Outcome Measure Information:
Title
Hemoglobin before delivery
Description
anemia prevalence at delivery
Time Frame
up to 32 weeks
Secondary Outcome Measure Information:
Title
Birthweight
Description
birthweight at term
Time Frame
measured once at birth
Title
Gestatonal age at birth
Description
percentage of preterm delivies in each arm
Time Frame
measured once at birth
Title
Discontinuation of iron or mulimineral supplementation
Description
discontinuation rate in every arm
Time Frame
delivery
Title
Ferritin before delivery
Description
body iron stores at delivery
Time Frame
up to 32 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Krafft, M.D
Phone
+41442551111
Email
alexander.krafft@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Krafft, MD
Organizational Affiliation
University Hospital Zurich, Div. of Obstetrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Dept of Obstetrics
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ALexander Krafft, MD
Phone
+41442551111
Email
alexander.krafft@usz.ch
First Name & Middle Initial & Last Name & Degree
Michele Stahel, MD
Phone
+41442551111
Email
michele.stahel@usz.ch

12. IPD Sharing Statement

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Different Iron Supplements for Prevention of Anemia in Pregnancy

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