Database Introduction: A Retrospective Study on Prophylactic Iron Supplementation with Shengxuening Tablet for Preventing Iron Deficiency Anemia in Pregnancy

1. Background
Iron homeostasis, crucial for physiological function, is disrupted during pregnancy due to impaired absorption (from gestational reactions and altered gut motility) and escalating fetal demands (post-16 weeks). Approximately 25% of women require increased iron intake in late gestation .
Iron deficiency (ID) progresses to iron deficiency anemia (IDA), elevating risks of adverse outcomes:
Maternal: Preterm premature rupture of membranes (PPROM), gestational hypertension, puerperal infection
Fetal/Neonatal: Growth restriction (FGR), preterm birth, low birth weight (LBW)
Regional epidemiology in China reveals significant disparities :
ID prevalence: East China (57.37%), Northeast (53.41%), Southwest (30.51%)
IDA prevalence: Central South (21.30%), Northwest (16.97%), East China (17.53%)
Prophylactic low-dose iron supplementation is recommended internationally to prevent ID→IDA progression while mitigating risks of iron overload.
2. Rationale and Objectives
Pathophysiological Basis
Serum ferritin <16.4 μg/L at 12 weeks signals need for intervention .
Pregnancy triples iron requirements vs. menstruation, reaching 30 mg/day elemental iron in mid-late gestation.
Once stores deplete, dietary iron is insufficient; oral supplementation (100–200 mg/day for IDA) is essential.
Non-anemic women with ferritin <30 μg/L require 60 mg/day elemental iron.
Iron excess risks gut dysbiosis [10] and gestational diabetes (GDM).
Shengxuening (SXN) Advantage
Active compound: Sodium ferrous chlorophyllin (heme iron) with superior bioavailability vs. non-heme iron.
Mechanism: Downregulates hepcidin and upregulates ferroportin to enhance iron absorption/transport.
Clinical evidence: A 498-patient multicenter trial demonstrated significantly lower anemia incidence with SXN vs. elemental iron or no supplementation.
3. Study Design and Objectives
This large-scale retrospective database study addresses critical evidence gaps by evaluating:
Primary Objectives
1. Iron Status & IDA Prevention:
Impact of prophylactic SXN on maternal iron biomarkers (serum ferritin, serum iron) and IDA incidence.
2. Maternal Outcomes:
Association with gestational diabetes (GDM), hypertensive disorders, preterm birth (<37 weeks), postpartum hemorrhage (PPH), and postpartum anemia.
3. Neonatal Outcomes:
Influence on low birth weight (LBW; <2500g), neonatal asphyxia, and fetal distress.
Scientific Value
By analyzing real-world data, this study will:
Establish efficacy of SXN in maintaining iron sufficiency
Evaluate safety profile for major maternal-fetal complications
Provide evidence for optimized prophylactic iron protocols.