Retrospective observational study to assess clinical impact of ferric pyrophosphate supplementation in antenatal settings of India (FEMINA study)

Background: Globally, anemia during pregnancy is a major public health concern. Conventional iron supplements limit their effectiveness due to poor absorption, water solubility and untoward GI side effects. This study assessed the clinical impact and safety of Micronized Microencapsulated Ferric Pyrophosphate (MMFP) supplementation in an antenatal setting of India. Methods: Real world, cross-sectional, single-arm, observational study in 814 patients from 122 clinics across India. Study done with central IEC approval in accordance with ICH-GCP and Helsinki Declaration. Descriptive and analytical statistics applied for study endpoints using SPSS ver. 29.0.1.0(171). Results: 814 pregnant women data was analysed with a mean age (29.39±3.98 years) and weight (59.48±8.14 kg). 61.79% patients were multiparous. 50.12% women were in their second trimester of pregnancy. Thyroid diseases were commonest comorbidity (21.25%). Mild anemia (37.35%) and moderate anemia (50.49%) were more prevalent. Hemoglobin levels showed significant improvement from 9.46±1.27 g/dl to 10.95±1.47 g/dl at 12 weeks (p<0.0001). Mean corpuscular volume (MCV) and serum ferritin also showed significant improvement from 85.31±9.49 fl to 90.93±8.51 fl and from 103.06±61.91 ng/ml to 164.42±79.61 ng/ml at 12 weeks (p<0.0001) respectively. Consistent improvement seen in three parameters irrespective of diet patterns or anemia severity at baseline. 12 weeks MMFP supplementation showed significant surge in patients having Hb (>11 g/dl) to 62.03% from 9.58% at baseline. Furthermore, MMFP demonstrated favourable safety profile, with only five mild adverse events observed, unrelated to the treatment. Conclusions: MMFP supplementation is a valuable therapeutic option for managing iron deficiency anemia in pregnant women.