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

Study of tolerability of iron liposome compared to ferrous sulphate in pregnant women with iron deficiency anemia.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000994-35-ES

Enrollment

130

Registered

2017-12-21

Start date

2018-08-02

Completion date

Unknown

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron deficiency anaemia MedDRA version: 20.0 Level: HLT Classification code 10002042 Term: Anaemia deficiencies System Organ Class: 100000004851

Interventions

Trade Name: Tardyferon Pharmaceutical Form: Tablet INN or Proposed INN: Dried ferrous sulphate BP CAS Number: 79102-61-7 Current Sponsor code: 52994 Other descriptive name: DRIED FERROUS SULPHATE BP C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Pregnant women diagnosed with iron deficiency anemia in second trimester analysis (week 24-28), understood as hemoglobin =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this study is to compare the tolerability of oral liposome iron versus oral ferrous sulfate in pregnant women diagnosed with iron deficiency anemia during the second trimester of pregnancy, based on the occurrence of side effects and adherence to treatment. A low-level clinical trial of pregnant women is proposed for this purpose, since the investigational drugs are authorized and used in accordance with the terms of the marketing authorization, and their use is supported by published scientific data on the safety and efficacy of the stated drugs. Moreover, no additional diagnostic procedures involving an additional risk or burden for the safety of the subjects will be carried out.;Secondary Objective: - To compare the efficacy of oral ferric pyrophosphate versus oral ferrous sulfate in pregnant women diagnosed with iron deficiency anemia during the second trimester of pregnancy, depending on the hemoglobin and hematocrit numbers. - Evaluate the quality of life of the patients according to the treatment administered. - Analyze the obstetric and perinatal outcomes in each treatment group.;Primary end point(s): The tolerability of oral ferric pyrophosphate versus oral ferrous sulfate will be compared in pregnant women diagnosed with iron deficiency anemia during the second trimester of pregnancy;Timepoint(s) of evaluation of this end point: Baseline, month 1, month 2, month 3	—

Measure

Time frame

Main Objective: The main objective of this study is to compare the tolerability of oral liposome iron versus oral ferrous sulfate in pregnant women diagnosed with iron deficiency anemia during the second trimester of pregnancy, based on the occurrence of side effects and adherence to treatment. A low-level clinical trial of pregnant women is proposed for this purpose, since the investigational drugs are authorized and used in accordance with the terms of the marketing authorization, and their use is supported by published scientific data on the safety and efficacy of the stated drugs. Moreover, no additional diagnostic procedures involving an additional risk or burden for the safety of the subjects will be carried out.;Secondary Objective: - To compare the efficacy of oral ferric pyrophosphate versus oral ferrous sulfate in pregnant women diagnosed with iron deficiency anemia during the second trimester of pregnancy, depending on the hemoglobin and hematocrit numbers. - Evaluate the quality of life of the patients according to the treatment administered. - Analyze the obstetric and perinatal outcomes in each treatment group.;Primary end point(s): The tolerability of oral ferric pyrophosphate versus oral ferrous sulfate will be compared in pregnant women diagnosed with iron deficiency anemia during the second trimester of pregnancy;Timepoint(s) of evaluation of this end point: Baseline, month 1, month 2, month 3

—

Secondary

Measure	Time frame
Secondary end point(s): Eficacy Quality of life Obstetrical and perinatal outcomes;Timepoint(s) of evaluation of this end point: Baseline, month 3	—

Countries

Spain

Contacts

Public ContactLucía Perez Silvestre

Hospital General Universitario de Alicante

perezsilvestre.lucia@gmail.com+34699438496

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026