Clinical trial NCT00746551: Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment
Official title: Low Dose Intravenous Versus Oral Iron for Iron Deficiency Anemia Starting Late in Pregnancy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Pregnancy Complications
Keywords: iron deficiency anemia
pregnancy
third trimester
intravenous iron
efficacy
a randomized trial
Female
Ferric Compounds/therapeutic use*
Infusions, Intravenous
Hematologic/therapy*
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Vifor Pharma
First posted: 2008-09-04
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of body iron storage replenishment between low dose intravenous iron and oral iron in late pregnancy.

Detailed description: Despite routine antenatal oral iron supplementation, the prevalence of iron deficiency anemia (IDA) in the 3rd trimester of pregnancy in developing countries remains high. Apparently, intravenous iron sucrose appears to be safe and efficient in treating within a short period. From literature review, no study of intravenous iron for IDA treatment has been carried out in the third trimester of pregnancy. This research aims to compare the efficacy of body iron storage replenishment at 3 weeks as labor may take place at this point in some women. In this study,500 mg intravenous iron has been given weekly instead of every other day for the sake of patient's convenience in the hope that parenteral iron may become another alternative for treatment of pregnant women with iron deficiency anemia who have difficulties or failures with oral iron.

Eligibility criteria: Inclusion Criteria:

1. Age 18-45 years old
2. Singleton pregnancy at 32 weeks gestation
3. Having anemia in the third trimester according to World Health Organization, namely, with a hemoglobin level of \< 11 g/dL or hematocrit of \< 33%
4. Having no underlying disease such as hypertension, gestational diabetes mellitus, heart disease, peptic ulcer, etc.
5. Having no history of allergy to iron containing medication
6. Having no history or other allergic conditions or asthma
7. Having no thalassemia disease, for examples: B thalassemia major, hemoglobin E/ B thalassemia, homozygous hemoglobin E, Hemoglobin H, AE Bart disease, and EF Bart disease. Pregnant women who have iron deficiency anemia and are thalassemia carriers such as A-thalassemia 1, B-thalassemia, or less severe Hb E/ B thalassemia are able to enter the study.
8. Having no history of bleeding tendency
9. Having no history of blood transfusion within the prior 120 days
10. Having no history of delivery before 36 weeks gestation
11. Giving consent and having signed the consent form for this study

Exclusion Criteria:

1. Stool exam revealed parasitic infestation
2. C-reactive protein \> 3 mg/L
3. Serum ferritin \> 15 mcg/L

Primary outcomes:
measure: Serum Ferritin Level
timeFrame: 3 weeks after intervention
Secondary outcomes:
measure: Haemoglobin Level
timeFrame: 3 weeks after intervention
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital, Mahidol University
Study officials:
affiliation: Obstetrics and Gynecology Department, Faculty of Medicine Siriraj Hosptial, Mahidol University
name: Pornpimol Ruangvutilert, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References: