Different Iron Supplements for Prevention of Anemia in Pregnancy

Pregnancy Clinical Trial

— EDISA  

Official title:

Effektivität Der in Der Schwangerschaftsvorsorge routinemässig Angewandten Eisenprophylaxe

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02487719
• Other study ID #: 2012-0475
• Status: Recruiting
• Phase: Phase 4
• First received: June 9, 2015
• Last updated: June 30, 2015
• Start date: June 2015
• Est. completion date: August 2016

Study information

• Verified date: June 2015
• Source: University of Zurich
• Contact: Alexander Krafft, M.D
• Phone: +41442551111
• Email: alexander.krafft[@]usz.ch
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron-Deficiency Anemia
• Pregnancy

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Dept of Obstetrics	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin before delivery	anemia prevalence at delivery	up to 32 weeks	No
Secondary	Birthweight	birthweight at term	measured once at birth	No
Secondary	Gestatonal age at birth	percentage of preterm delivies in each arm	measured once at birth	No
Secondary	Discontinuation of iron or mulimineral supplementation	discontinuation rate in every arm	delivery	No
Secondary	Ferritin before delivery	body iron stores at delivery	up to 32 weeks	No