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Study on iron supplementation therapy in pregnant women with non–transfusion-dependent thalassemia.

A randomized controlled study on the effects of iron supplementation during pregnancy on maternal and neonatal outcomes in pregnant women with non–transfusion-dependent thalassemia.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113608
Enrollment
Unknown
Registered
2025-12-01
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Thalassemia

Interventions

Pregnant women with NTDT iron supplementation group:Ferrous fumarate, 60 mg/day
Pregnancy with NTDT without iron supplementation group:Blank control
Normal pregnancy control group:Ferrous fumarate, 60 mg/day

Sponsors

Chongqing Health Center for Women and Children
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Those who voluntarily participate and complete informed consent; 2. Singleton pregnancy; 3. Patients with thalassemia confirmed by abnormal blood routine/hemoglobin and thalassemia gene detection; 4. Pregnant women with normal blood routine/hemoglobin; 5. Ferritin > 20µg/L; 6. Hb >=90 g/L; 7. Regular prenatal examination in our hospital can complete the follow-up;

Exclusion criteria

Exclusion criteria: 1. Refusal to participate; 2. Multiple pregnancy; 3. Pregnant women with systemic diseases (such as hypertension, diabetes, thyroid dysfunction, tumor, hepatitis, heart disease, etc.); 4. Thalassemia combined with iron deficiency anemia (Hb <110g/L, ferritin < 20µg/L); 5. Thalassemia patients with Hb < 90g/L who may need blood transfusion; 6. Failure to complete follow-up;

Design outcomes

Primary

MeasureTime frame
Hemoglobin level;Ferritin levels;

Secondary

MeasureTime frame
AST, ALT levels;Cardiac function was evaluated by echocardiography (ejection fraction, end-diastolic volume, pulmonary artery systolic pressure, etc.);Incidence of pregnancy complications (preeclampsia, gestational diabetes mellitus, preterm birth, premature rupture of membranes, etc.);Fetal birth resolution (birth weight, APGAR score, NICU admission rate and duration, fetal hemoglobin level);Incidence of iron deficiency anemia in offspring at 6 months;

Countries

China

Contacts

Public ContactLiao Jiujiang

Chongqing Health Center for Women and Children

496035782@qq.com+86 23 60354500

Outcome results

None listed

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