Feasibility or Oral Lactoferrin to Prevent Iron Deficiency Anemia in Obese Pregnancy

Obesity Clinical Trial

Official title:

Feasibility or Oral Lactoferrin to Prevent Iron Deficiency Anemia in Obese Pregnancy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04810546
• Other study ID #: 2020-1297
• Secondary ID: R34HL155481
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Maternal iron deficiency anemia is associated with maternal and infant mortality, spontaneous preterm birth, maternal postpartum hemorrhage, and neurocognitive defects in the neonate. Therefore, preventing maternal iron deficiency anemia in at-risk women is critical. Obese pregnant women have greater systemic inflammation and circulating hepcidin levels compared to nonobese pregnant women. This phenotype implies obese pregnant women have decreased iron bioavailability and may be less responsive to oral iron supplementation because hepcidin is a negative regulator of dietary iron absorption, suggesting alternative interventions are needed to optimize their iron status in pregnancy. There is increasing evidence that consuming the oral bovine lactoferrin (bLf) can enhance dietary iron absorption by promoting an anti-inflammatory immune response and hepcidin suppression, indicating this intervention may be beneficial to pregnant obese women at risk for iron deficiency anemia. The primary goal of this study is to test the feasibility and acceptability of this low-cost, safe, innovative approach to optimizing maternal iron status in obese women at risk of iron deficiency anemia (Hb 11.0 - 12.0 g/dL (first trimester)/10.5 - 11.5 g/dL (second trimester) for non-Black women and 10.2 - 11.2 g/dL (first trimester)/9.7 -- 10.7 g/dL (second trimester) for Black women) from 15-20 weeks of gestation (WG) until the time of labor. The investigators will explore effects on maternal and neonatal iron status and Hb and changes to maternal systemic inflammation and circulating hepcidin. This study is an essential first step toward evaluating if daily oral bLf is an efficacious, safe, inexpensive, and scalable clinical strategy for the prevention of maternal iron deficiency anemia and its related complications in at-risk women.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• naturally conceived, single pregnancy

• at risk of IDA [Hb 11.0 - 12.0 g/dL (first trimester)/10.5 - 11.5 g/dL (second trimester) for non-Black women and 10.2 - 11.2 g/dL (first trimester)/9.7 -- 10.7 g/dL (second trimester) for Black women]42 based on new OB complete blood count (CBC) results obtained from the EMR

• 18 - 45 years old

• pre-conception BMI = 30.0 kg/m2 [based on measured height in EMR and recent pre-conception weight (within 3 months of pregnancy) from EMR if available or self-reported]; < 20 WG

• fluency in English to provide consent and complete study procedures;

• ability to provide consent

• ownership of a smartphone (currently more than 90% of our patient population at the Center for Women's Health)

Exclusion Criteria:

• birth, or other pregnancy in the previous 12 months

• IDA requiring high dose supplemental iron

• allergy to milk proteins or wheat

• vegan (due to content of the supplements)

• recent blood transfusion

• previously diagnosed type 1 or type 2 diabetes

• autoimmune disorder (e.g., rheumatoid arthritis)

• inflammatory bowel disease

• premature rupture of membranes or chorioamnionitis

• previous spontaneous preterm birth

• current bacterial or viral infection

• history of bariatric surgery

• malabsorptive disease

• current hyperemesis

• current eating disorder

• hematologic disorder or trait carrier (e.g., hemochromatosis, ß-thalassemia)

• current tobacco, alcohol or illicit drug use (including marijuana)

• regular use of medications that may interfere with nutrient absorption

• unstable housing, first trimester PHQ-9 score > 10, and/or a recent traumatic event (e.g., death of a significant other or parent) may make it difficult to comply with the interventions, hence these women will also be excluded.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron-deficiency
• Obesity
• Pregnancy Anemia

Intervention

Dietary Supplement:
• Jarrow Formulas Oral Bovine Lactoferrin Supplement
Lactoferrin (Apolactoferrin) 250mg contains ~17.6 mg/100g of iron

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Understand feasibility via recruitment and retention rates	We will collect detailed records of the number of women eligible and then referred by Center for Women's Health clinical staff to the research team. We will also track the number of referred women approached (by phone & in person) by our research team for enrollment and the number of women who decline and their reasons for non-enrollment. Once a woman is enrolled in the study, attendance at study visits, completeness of data, and overall and treatment specific loss to follow-up/withdrawal will be closely monitored. Women who voluntarily withdraw will be asked to provide reasons for revoking their enrollment. Rates of enrollment and retainment are key feasibility outcomes. To facilitate recruitment and retention, transportation and participation monetary incentives will be provided. Data will be evaluated to determine feasibility of this kind of reasearch	Recruitment duration- approximately 3 years
Primary	Measure participant adherence	For both study arms, the Pillsy smart bottle, phone app, and researcher interface configured, tested and finalized in Aim 1 will be used to optimize adherence. The smart bottle will send reminders (i.e., the pill bottle rings and lights up) at a time selected by the participant congruent with their intervention arm assignment (e.g., at bedtime). Use of the Pillsy app will allow for "real-time" tracking of the participant's adherence through the HIPAA-compliant researcher interface. If a participant is non-adherent for two consecutive days additional alerts (e.g., text messages) will be triggered through the research interface two-way communication feature, and study staff will make contact (i.e., telephone/text/email). Hand pill counts will also be performed by UIC Investigational Drug Service. Smart bottles will generate individual reports detailing how many pills were taken and when. A report detailing dates and times of pills being taken will be used to measure adherence	8 months
Primary	Determine preliminary efficacy on maternal inflammation	Maternal IL-6. Inflammation, specifically the pro-inflammatory cytokine IL-6, is a positive regulator of hepcidin. Maternal IL-6 will be measured in serum at baseline with a commercially-available ELISA (R&D Systems, Minneapolis, MN). Our lab's intra-assay CV is 5.7%. Expected results: We expect significantly lower IL-6 at 19-24 weeks gestation that is maintained through delivery in women randomized to oral Lf compared with control.	baseline
Primary	Determine preliminary efficacy on maternal inflammation	Maternal IL-6. Inflammation, specifically the pro-inflammatory cytokine IL-6, is a positive regulator of hepcidin. Maternal IL-6 will be measured in serum at 23-28 weeks gestation (month 3) with a commercially-available ELISA (R&D Systems, Minneapolis, MN). Our lab's intra-assay CV is 5.7%. Expected results: We expect significantly lower IL-6 at 19-24 weeks gestation that is maintained through delivery in women randomized to oral Lf compared with control.	month 3
Primary	Determine preliminary efficacy on maternal inflammation	Maternal IL-6. Inflammation, specifically the pro-inflammatory cytokine IL-6, is a positive regulator of hepcidin. Maternal IL-6 will be measured in serum at 31-36 weeks gestation (month 5) with a commercially-available ELISA (R&D Systems, Minneapolis, MN). Our lab's intra-assay CV is 5.7%. Expected results: We expect significantly lower IL-6 at 19-24 weeks gestation that is maintained through delivery in women randomized to oral Lf compared with control.	month 5
Primary	Determine preliminary efficacy on maternal inflammation	Maternal IL-6. Inflammation, specifically the pro-inflammatory cytokine IL-6, is a positive regulator of hepcidin. Maternal IL-6 will be measured in serum at admittance for labor and delivery with a commercially-available ELISA (R&D Systems, Minneapolis, MN). Our lab's intra-assay CV is 5.7%. Expected results: We expect significantly lower IL-6 at 19-24 weeks gestation that is maintained through delivery in women randomized to oral Lf compared with control.	labor (~month 8)
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood at baseline; • Ferritin & Iron. Maternal ferritin and iron will be measured in serum by immunoassay and spectrophotometry by a local commercial lab	baseline
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood at baseline; • sTFR. Maternal sTFR will be measured in serum using a commercially available immunoassay (ELISA) (R&D Systems, Minneapolis, MN). Our lab's intra-assay coefficient of variation (CV) for this kit is 5.3%.	baseline
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood at baseline; • Calculated Total Body Iron (TBI). Maternal TBI will be calculated from sTFR and serum ferritin using an equation developed by Cook and colleagues.	baseline
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood at baseline; • Complete Blood Count (CBC). Maternal CBC with differential will be measured in whole blood by electronic cell sizing/counting/cytometry/microscopy by a local commercial lab). Hb is the primary clinical outcome for the trial given it is the most commonly assessed iron/hematological status marker in pregnancy.	baseline
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • Ferritin & Iron. Maternal ferritin and iron will be measured in serum by immunoassay and spectrophotometry by a local commercial lab	1 month
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • sTFR. Maternal sTFR will be measured in serum using a commercially available immunoassay (ELISA) (R&D Systems, Minneapolis, MN). Our lab's intra-assay coefficient of variation (CV) for this kit is 5.3%.	1 month
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • Calculated Total Body Iron (TBI). Maternal TBI will be calculated from sTFR and serum ferritin using an equation developed by Cook and colleagues.	1 month
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • Complete Blood Count (CBC). Maternal CBC with differential will be measured in whole blood by electronic cell sizing/counting/cytometry/microscopy by a local commercial lab). Hb is the primary clinical outcome for the trial given it is the most commonly assessed iron/hematological status marker in pregnancy.	1 month
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • Ferritin & Iron. Maternal ferritin and iron will be measured in serum by immunoassay and spectrophotometry by a local commercial lab	2 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • sTFR. Maternal sTFR will be measured in serum using a commercially available immunoassay (ELISA) (R&D Systems, Minneapolis, MN). Our lab's intra-assay coefficient of variation (CV) for this kit is 5.3%.	2 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • Calculated Total Body Iron (TBI). Maternal TBI will be calculated from sTFR and serum ferritin using an equation developed by Cook and colleagues.	2 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • Complete Blood Count (CBC). Maternal CBC with differential will be measured in whole blood by electronic cell sizing/counting/cytometry/microscopy by a local commercial lab). Hb is the primary clinical outcome for the trial given it is the most commonly assessed iron/hematological status marker in pregnancy.	2 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • Ferritin & Iron. Maternal ferritin and iron will be measured in serum by immunoassay and spectrophotometry by a local commercial lab	3 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • sTFR. Maternal sTFR will be measured in serum using a commercially available immunoassay (ELISA) (R&D Systems, Minneapolis, MN). Our lab's intra-assay coefficient of variation (CV) for this kit is 5.3%.	3 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • Calculated Total Body Iron (TBI). Maternal TBI will be calculated from sTFR and serum ferritin using an equation developed by Cook and colleagues.	3 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood at monthly.; • Complete Blood Count (CBC). Maternal CBC with differential will be measured in whole blood by electronic cell sizing/counting/cytometry/microscopy by a local commercial lab). Hb is the primary clinical outcome for the trial given it is the most commonly assessed iron/hematological status marker in pregnancy.	3 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • Ferritin & Iron. Maternal ferritin and iron will be measured in serum by immunoassay and spectrophotometry by a local commercial lab	4 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • sTFR. Maternal sTFR will be measured in serum using a commercially available immunoassay (ELISA) (R&D Systems, Minneapolis, MN). Our lab's intra-assay coefficient of variation (CV) for this kit is 5.3%.	4 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • Calculated Total Body Iron (TBI). Maternal TBI will be calculated from sTFR and serum ferritin using an equation developed by Cook and colleagues.	4 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • Complete Blood Count (CBC). Maternal CBC with differential will be measured in whole blood by electronic cell sizing/counting/cytometry/microscopy by a local commercial lab). Hb is the primary clinical outcome for the trial given it is the most commonly assessed iron/hematological status marker in pregnancy.	4 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • Ferritin & Iron. Maternal ferritin and iron will be measured in serum by immunoassay and spectrophotometry by a local commercial lab	5 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • sTFR. Maternal sTFR will be measured in serum using a commercially available immunoassay (ELISA) (R&D Systems, Minneapolis, MN). Our lab's intra-assay coefficient of variation (CV) for this kit is 5.3%.	5 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • Calculated Total Body Iron (TBI). Maternal TBI will be calculated from sTFR and serum ferritin using an equation developed by Cook and colleagues.	5 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • Complete Blood Count (CBC). Maternal CBC with differential will be measured in whole blood by electronic cell sizing/counting/cytometry/microscopy by a local commercial lab). Hb is the primary clinical outcome for the trial given it is the most commonly assessed iron/hematological status marker in pregnancy.	5 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • Ferritin & Iron. Maternal ferritin and iron will be measured in serum by immunoassay and spectrophotometry by a local commercial lab	6 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • sTFR. Maternal sTFR will be measured in serum using a commercially available immunoassay (ELISA) (R&D Systems, Minneapolis, MN). Our lab's intra-assay coefficient of variation (CV) for this kit is 5.3%.	6 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • Calculated Total Body Iron (TBI). Maternal TBI will be calculated from sTFR and serum ferritin using an equation developed by Cook and colleagues.	6 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • Complete Blood Count (CBC). Maternal CBC with differential will be measured in whole blood by electronic cell sizing/counting/cytometry/microscopy by a local commercial lab). Hb is the primary clinical outcome for the trial given it is the most commonly assessed iron/hematological status marker in pregnancy.	6 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • Ferritin & Iron. Maternal ferritin and iron will be measured in serum by immunoassay and spectrophotometry by a local commercial lab	7 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • sTFR. Maternal sTFR will be measured in serum using a commercially available immunoassay (ELISA) (R&D Systems, Minneapolis, MN). Our lab's intra-assay coefficient of variation (CV) for this kit is 5.3%.	7 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • Calculated Total Body Iron (TBI). Maternal TBI will be calculated from sTFR and serum ferritin using an equation developed by Cook and colleagues.	7 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood monthly; • Complete Blood Count (CBC). Maternal CBC with differential will be measured in whole blood by electronic cell sizing/counting/cytometry/microscopy by a local commercial lab). Hb is the primary clinical outcome for the trial given it is the most commonly assessed iron/hematological status marker in pregnancy.	7 months
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood at admittance for delivery.; • Ferritin & Iron. Maternal ferritin and iron will be measured in serum by immunoassay and spectrophotometry by a local commercial lab	delivery (~8 months)
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood at admittance for delivery.; • sTFR. Maternal sTFR will be measured in serum using a commercially available immunoassay (ELISA) (R&D Systems, Minneapolis, MN). Our lab's intra-assay coefficient of variation (CV) for this kit is 5.3%.	delivery (~8 months)
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood at admittance for delivery.; • Calculated Total Body Iron (TBI). Maternal TBI will be calculated from sTFR and serum ferritin using an equation developed by Cook and colleagues.	delivery (~8 months)
Primary	Determine preliminary efficacy on maternal iron and hematological markers.	Maternal iron status and hematological parameters will be assessed from antecubital non-fasting blood at admittance for delivery.; • Complete Blood Count (CBC). Maternal CBC with differential will be measured in whole blood by electronic cell sizing/counting/cytometry/microscopy by a local commercial lab). Hb is the primary clinical outcome for the trial given it is the most commonly assessed iron/hematological status marker in pregnancy.	delivery (~8 months)
Primary	Determine preliminary efficacy on maternal hematological markers.	Maternal Hepcidin. Maternal hepcidin will be measured in serum at baseline with a commercially available ELISA. The minimum level of detection for the assay is 2.5 ng/mL.	Baseline
Primary	Determine preliminary efficacy on maternal hematological markers.	Maternal IL-6. Inflammation, specifically the pro-inflammatory cytokine IL-6, is a positive regulator of hepcidin. Maternal IL-6 will be measured in serum at baseline with a commercially-available ELISA (R&D Systems, Minneapolis, MN). Our lab's intra-assay CV is 5.7%.	Baseline
Primary	Determine preliminary efficacy on maternal hematological markers.	. Maternal Erythropoietin. Erythropoiesis is a negative regulator of hepcidin. Maternal erythropoietin will be measured in serum at baseline with a commercially available ELISA (R&D Systems, Minneapolis, MN). Our lab's intra-assay CV is 2.6%.	Baseline
Primary	Determine preliminary efficacy on maternal hematological markers.	Maternal Hepcidin. Maternal hepcidin will be measured in serum at 3 months with a commercially available ELISA. The minimum level of detection for the assay is 2.5 ng/mL.	3 months
Primary	Determine preliminary efficacy on maternal hematological markers.	Maternal IL-6. Inflammation, specifically the pro-inflammatory cytokine IL-6, is a positive regulator of hepcidin. Maternal IL-6 will be measured in serum at 3 months with a commercially-available ELISA (R&D Systems, Minneapolis, MN). Our lab's intra-assay CV is 5.7%.	3 months
Primary	Determine preliminary efficacy on maternal hematological markers.	Maternal Erythropoietin. Erythropoiesis is a negative regulator of hepcidin. Maternal erythropoietin will be measured in serum at 3 months with a commercially available ELISA (R&D Systems, Minneapolis, MN). Our lab's intra-assay CV is 2.6%.	3 months
Primary	Determine preliminary efficacy on maternal hematological markers.	Maternal Hepcidin. Maternal hepcidin will be measured in serum at 5 months with a commercially available ELISA. The minimum level of detection for the assay is 2.5 ng/mL.	5 months
Primary	Determine preliminary efficacy on maternal hematological markers.	Maternal IL-6. Inflammation, specifically the pro-inflammatory cytokine IL-6, is a positive regulator of hepcidin. Maternal IL-6 will be measured in serum at 5 months with a commercially-available ELISA (R&D Systems, Minneapolis, MN). Our lab's intra-assay CV is 5.7%.	5 months
Primary	Determine preliminary efficacy on maternal hematological markers.	Maternal Erythropoietin. Erythropoiesis is a negative regulator of hepcidin. Maternal erythropoietin will be measured in serum at 5 months with a commercially available ELISA (R&D Systems, Minneapolis, MN). Our lab's intra-assay CV is 2.6%.	5 months
Primary	Determine preliminary efficacy on maternal hematological markers.	Maternal Hepcidin. Maternal hepcidin will be measured in serum at admittance for labor and delivery with a commercially available ELISA. The minimum level of detection for the assay is 2.5 ng/mL.	Delivery (~8 months)
Primary	Determine preliminary efficacy on maternal hematological markers.	Maternal IL-6. Inflammation, specifically the pro-inflammatory cytokine IL-6, is a positive regulator of hepcidin. Maternal IL-6 will be measured in serum at admittance for labor and delivery with a commercially-available ELISA (R&D Systems, Minneapolis, MN). Our lab's intra-assay CV is 5.7%.	Delivery (~8 months)
Primary	Determine preliminary efficacy on maternal hematological markers.	Maternal Erythropoietin. Erythropoiesis is a negative regulator of hepcidin. Maternal erythropoietin will be measured in serum at admittance for labor and delivery with a commercially available ELISA (R&D Systems, Minneapolis, MN). Our lab's intra-assay CV is 2.6%.	Delivery (~8 months)
Primary	Determine preliminary efficacy on neonatal iron and hematological markers.	Neonatal cord iron status and hematologic parameters will be assessed from venous umbilical cord blood obtained bedside following delivery of the placenta. Even with delayed umbilical cord-clamping, we can successfully obtain 40-50 milliliters of umbilical venous cord blood.; • Cord Ferritin & Iron. Cord ferritin and iron will be measured in serum by immunoassay and spectrophotometry at a local commercial lab (Quest Diagnostics, Wood Dale, IL).	Delivery (~8 months)
Primary	Determine preliminary efficacy on neonatal iron and hematological markers.	Neonatal cord iron status and hematologic parameters will be assessed from venous umbilical cord blood obtained bedside following delivery of the placenta. Even with delayed umbilical cord-clamping, we can successfully obtain 40-50 milliliters of umbilical venous cord blood.; • Cord sTFR. Cord sTFR will be measured with an immunoassay (ELISA) (R&D Systems, Minneapolis, MN). Our lab's intra-assay coefficient of variation (CV) for this kit is 5.3%.	Delivery (~8 months)
Primary	Determine preliminary efficacy on neonatal iron and hematological markers.	Neonatal cord iron status and hematologic parameters will be assessed from venous umbilical cord blood obtained bedside following delivery of the placenta. Even with delayed umbilical cord-clamping, we can successfully obtain 40-50 milliliters of umbilical venous cord blood.; • Cord TBI. Cord TBI will be calculated from cord sTFR and serum ferritin using a published equation.	Delivery (~8 months)
Primary	Determine preliminary efficacy on neonatal iron and hematological markers.	Neonatal cord iron status and hematologic parameters will be assessed from venous umbilical cord blood obtained bedside following delivery of the placenta. Even with delayed umbilical cord-clamping, we can successfully obtain 40-50 milliliters of umbilical venous cord blood.; • Cord CBC. Cord CBC with differential, which includes Hb, will be measured by electronic cell sizing/counting/cytometry/microscopy at a local commercial lab (Quest Diagnostics, Wood Dale, IL).	Delivery (~8 months)