Different Iron Supplements for Prevention of Anemia in Pregnancy

NCT02487719 | Unknown Phase 4

• 1 other identifier: 2012-0475
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron-Deficiency Anemia; Pregnancy

Keywords

Iron deficiecy; pregnancy; prenatal care

Outcome Measures

Primary Outcomes (1)

• Hemoglobin before delivery

  anemia prevalence at delivery

  up to 32 weeks

Secondary Outcomes (4)

• Birthweight

  measured once at birth

• Gestatonal age at birth

  measured once at birth

• Discontinuation of iron or mulimineral supplementation

  delivery

• Ferritin before delivery

  up to 32 weeks

Study Arms (3)

Iron sulfate

ACTIVE COMPARATOR

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

Iron polymaltose

ACTIVE COMPARATOR

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

Multimineral

NO INTERVENTION

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

Interventions

Iron sulfate and Iron polymaltose for prevention of iron deficiency anemia DRUG

Also known as: gynotardiferon, maltofer, elevit

Iron polymaltose; Iron sulfate

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Dept of Obstetrics

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Iron-Dextran Complex; teferrol

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Alexander Krafft, MD

  University Hospital Zurich, Div. of Obstetrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Krafft, M.D

CONTACT

+41442551111; alexander.krafft@usz.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: July 1, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: July 1, 2015

Record last verified: 2015-06

Locations

CH (1)