Study to compare two treatments in iron deficiency anemia in pregnant wome

Phase 1

Active, not recruiting

• Conditions: Iron deficiency anaemia; MedDRA version: 20.0Level: HLTClassification code 10002042Term: Anaemia deficienciesSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2017-000994-35-ES
• Lead Sponsor: Hospital General Universitario de Alicante

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-21
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

-Pregnant women diagnosed with iron deficiency anemia in second trimester analysis (week 24-28), understood as hemoglobin <11 g / dL, serum ferritin <12 and hematocrit <33%.
-Pregnant women aged 18 or over.
- Single pregnancy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

· Anemia from other causes.
· Blood transfusion, treatment with oral or intravenous iron one month prior to analytical analysis of the second quarter.
· Chronic maternal medical pathology prior to gestation (clinical and/or analitic evidence of hepatic, renal, pulmonary, haematological or cardiovascular abnormalities, history of peptic ulcer
• Women with dietary restrictions (allergies or food intolerances). Women with specific dietary patterns (vegetarian or vegan).
• Hypersensitivity to iron supplements.
• Lactose intolerance.
• Severe anemia: hemoglobin <9 g/dl
· Fetal pathology: chromosomal abnormalities or fetal malformations on ultrasound.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified