iron deficiendy anemia iron deficiency anemia, pregnnacy
Conditions
Interventions
This study aims to assess the improvement of anemia following high-dose intravenous iron therapy in pregnant women with anemia during late pregnancy.
D007501
high-dose intravenous iron
Sponsors
Kumagai Asako
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Patients aged 18 years or older at the time of consent 2) Patients with iron deficiency anemia and requiring iron supplementation, as determined by blood tests performed at the 34th week of pregnancy and showing both 1and 2 of the following 1 Microcytic or normocytic anemia (Hb<11g/dl) 2 Ferritin level 25 ng/mL or T-SAT (serum iron/TIBC) level 0.2 or less 3) Outpatients 4) Patients with singleton pregnancies 5) Patients with a pre-pregnancy weight of 40 kg or more 6) Patients who are competent to consent and can provide written informed consent of their own free will 7) Patients who, after considering the inclusion and exclusion criteria, are deemed by the principal investigator (subinvestigator) to be able to appropriately evaluate the efficacy and safety of this study.
Exclusion criteria
Exclusion criteria: 1) Patients with underlying chronic inflammatory diseases (collagen disease, diabetes, ulcerative colitis, Crohn's disease) 2) Patients with blood disorders other than anemia 3) Patients with severe heart, kidney, or liver disease 4) Patients with preeclampsia 5) Patients with anemia due to causes other than iron deficiency anemia 6) Patients with hypophosphatemia 7) Patients already receiving high-dose iron infusions or blood transfusions during pregnancy 8) Patients with or a history of drug hypersensitivity to Monovar or oral iron supplements 9) Patients with fetal growth restriction or congenital fetal disorders 10) Patients deemed inappropriate for participation in this study by the principal investigator (subinvestigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in Hb from baseline at 34 weeks to pre-delivery measurement | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Nutritional intake at 36 weeks 2) Blood loss during delivery by vaginal delivery and cesarean section 3) Newborn birth weight 4) Changes from baseline (34 weeks gestation) in iron, ferritin, and TIBC levels immediately prior to delivery 5) Normal rate (proportion of patients with a maximum Hb level of 11.0 g/dL or greater) (from 36 weeks gestation to immediately prior to delivery) 6) Effective rate (proportion of patients with a maximum change in Hb level of +2.0 g/dL or greater from baseline (34 weeks gestation) to immediately prior to delivery) 7) Hb, ferritin, TIBC, EPDS, EQ5D, and breastfeeding success rate at the 1-month checkup | — |
Contacts
Public ContactAsako Kumagai
Juntendo University Hospital
Outcome results
None listed