Real-World Effectiveness of IHATTM in Women with Iron Deficiency Across Pregnancy, Postpartum and Abnormal Uterine Bleeding.

Objective: To evaluate the real-world effectiveness and tolerability of Iron Hydroxide Adipate Tartrate (IHATTM) in women with iron deficiency across three common obstetric and gynecologic clinical settings: pregnancy, the postpartum period, and abnormal uterine bleeding. Methods: This prospective multicenter observational real-world study included women with iron deficiency managed in routine clinical practice across Italy. Participating gynecologists collected data using standardized case report forms. Patients received IHATTM according to routine clinical practice and were followed for approximately three months. Baseline demographic and hematologic parameters were recorded, including hemoglobin and ferritin levels. The primary outcome was the change in hemoglobin between baseline and follow-up. Secondary outcomes included changes in ferritin levels, treatment adherence, and tolerability. Results: A total of 517 women was included in the analysis. The study population included pregnant women (N = 287, 55.5%), women with abnormal uterine bleeding (N = 161, 31.1%), and women in the postpartum period (N = 69, 13.3%). Improvements in hemoglobin were observed across all clinical settings, with hemoglobin increasing from 10.35 g/dL at baseline to 11.63 g/dL at three months, corresponding to a mean increase of 1.28 g/dL. Mean ferritin levels increased from 22.50 ng/mL to 37.74 ng/mL in three months. Treatment adherence was high or moderate in 93.4% of patients. Gastrointestinal adverse events were infrequent, with constipation (9.7%) and nausea (4.8%) among the most reported. Conclusions: In this prospective real-world multicenter study, treatment with IHATTM was associated with meaningful improvements in hemoglobin and iron stores in women with iron deficiency across pregnancy, postpartum, and abnormal uterine bleeding. The treatment showed good adherence and a favorable tolerability profile in routine clinical practice.