Anemia remains a major contributor to maternal morbidity and mortality and, despite numerous efforts, rates of anemia have not decreased, especially in low- and middle-income countries. The most common cause of anemia worldwide is iron deficiency, and anemia due to this cause will be referred to as iron deficiency anemia (IDA). And while IDA during pregnancy increases the risk of adverse maternal, fetal, and neonatal outcomes, it is important to address other periods, particularly immediately after delivery when maternal hemoglobin values often drop precipitously. An intravenous (IV) iron infusion has been demonstrated to be a safe, effective intervention to reduce anemia during pregnancy but has not been adequately assessed during the postpartum period. To reduce anemia among women of reproductive age, new, effective interventions are needed. Thus, this trial, Postpartum IV Iron to Treat Iron-Deficiency Anemia (PRIORITY Trial), will determine if a single-dose intravenous (IV) infusion of iron is a more effective means of increasing prevalence of non-anemia than standard of care of oral iron (folate will be given to all participants as per local guidelines) among postpartum women with Hb 7-9.9 g/dL.

Background: Anemia remains a major contributor to maternal morbidity and mortality and, despite numerous efforts, rates of anemia have not decreased, especially in low- and middle-income countries. The most common cause of anemia worldwide is iron deficiency, and anemia due to this cause will be referred to as iron deficiency anemia (IDA). And while IDA during pregnancy increases the risk of adverse maternal, fetal, and neonatal outcomes, it is important to address other periods, particularly immediately after delivery when maternal hemoglobin values often drop precipitously. An intravenous (IV) iron infusion has been demonstrated to be a safe, effective intervention to reduce anemia during pregnancy but has not been adequately assessed during the postpartum period. To reduce anemia among women of reproductive age, new, effective interventions are needed. Thus, this trial, Postpartum IV Iron to Treat Iron-Deficiency Anemia (PRIORITY Trial), will determine if a single-dose intravenous (IV) infusion of iron is a more effective means of increasing prevalence of non-anemia than standard of care of oral iron (folate will be given to all participants as per local guidelines) among postpartum women with Hb 7-9.9 g/dL.

Primary Hypothesis: At 6 weeks post-delivery, achievement of non-anemic state (defined as Hb ≥11 g/dL) will be greater among women receiving IV iron (Arm 1) than among women receiving standard care with oral iron (Arm 2) (both treatments will be given with or without folate as per local guidelines).

Study Design: Two-arm, prospective, randomized trial.

Population: Women (n=4,800, in total) with moderate hemoglobin (Hb) concentrations (7-9.9 g/dL) immediately post-delivery (6-48 hours), who deliver at study hospitals or birthing facilities in Global Network sites (Bangladesh, India [2 sites], Pakistan, Democratic Republic of Congo, Kenya, Zambia and Guatemala).

Treatment Arms:

Intervention: Single dose IV iron ± folate as per local guidelines (Arm 1)

Comparison: Standard care (oral iron ± folate as per local guidelines) (Arm 2)

Primary outcome:

Maternal non-anemic state (Hb >11 g/dL) at 6 weeks post-delivery

Secondary outcomes:

Maternal

• Maternal mortality (from delivery to 6 mo post-delivery)
• Post-discharge blood transfusion through 6 mo post-delivery
• Postpartum hemorrhage (from intervention through 6 wk post-delivery) requiring transfusion or major surgery
• Hospitalization (as an indicator to capture infection through 6 mo post-delivery)
• Documentation of intrapartum complications (diabetes, preeclampsia, fetal demise)
• Rate of screening for postpartum depression (6 wk, 6 mo)
• Maternal fatigue severity scores (6 wk, 6 mo)
• Infant-mother bonding scale scores (6 wk
• Quality of life assessment scores (6 wk, 6 mo)
• Prevalence of severe/moderate/mild anemia (also at time of recruitment and at 6 mo)
• Change resulting in severe/moderate/mild anemia by treatment arm (6 mo)
• Hemoglobin concentration by mode of delivery (6 mo)
• Differences in ferritin and inflammatory markers on all randomized patients (delivery, 6 wk, 6 mo)
• Hb concentration and ferritin measured in first trimester of an intercurrent pregnancy

Infant

• Neonatal/infant mortality (birth to 6 mo)
• Infant hospitalization (birth to 6 mo)
• Exclusive breastfeeding rate (6 wk, 6 mo) and intent to continue breastfeeding through 12 mo post-delivery (6 mo)