Use of Cast Iron Pots to Improve Maternal Anemia

Anemia of pregnancy is defined as a hemoglobin concentration of less than 11 g/dL in the first and third trimesters, and less than 10.5 g/dL in the second trimester. The rates of anemia are variable and depend largely on preexisting iron stores and supplementation. Estimates from the World Health Organization report that 35% to 75% of pregnant women in developing countries and 18% of women from industrialized countries are anemic. Maternal anemia is associated with an increased risk of preterm birth, low birthweight, and small for gestational age infants. Many studies have shown improvement in these outcomes with maternal iron supplementation in cases of iron-deficiency anemia. Mounting evidence also indicates that maternal iron deficiency in pregnancy reduces fetal iron stores, perhaps well into the first year of life.

Anemia in pregnancy can also impact maternal morbidity and mortality. Viteri reported that anemic pregnant women are at greater risk of death during the perinatal period and that anemia is the major contributory or sole cause of death in 20-40% of the 500,000 maternal deaths per year.

The need for iron averages close to 1000mg in a typical singleton gestation. This amount considerably exceeds the iron stores of most women and will result in iron-deficiency anemia unless supplemental iron is taken. One problem with iron supplement use is compliance, secondary to adverse effects such as constipation and nausea. Research on the use of cast iron pots in decreasing the incidence of iron-deficiency anemia in non-pregnant women has been promising. These studies have demonstrated good compliance with no reported adverse effects. The aim of our study is to determine if providing anemic women in the first trimester of pregnancy with a cast iron pot will decrease the incidence of anemia later in pregnancy.

Hypothesis: Cooking in cast iron pots will increase hematocrit levels in pregnancy.

Study Overview

• Status: Terminated
• Conditions: Iron-deficiency Anemia
• Intervention / Treatment: Device: Cast Iron Pot; Device: Alumnium Pot

Detailed Description

Research Question: Will the addition of cast iron pots to the standard of care (nutrition counseling, food recall, prenatal vitamin, +/- iron and vit c) improve the hematocrit of pregnant women with anemia? Study Intervention: To provide a cast iron pot to those pregnant women with anemia who are randomized to intervention group and an aluminum pot to those women in the control group. Women will be blinded to their allocation. Women with a qualifying hemoglobin will meet with our nutritionist (as they would if not enrolled in the study), and she will perform a standardized 24 hour food recall and nutrition counseling according to the standard of care, as well as perform written informed consent. The 24 hour food recall will be submitted to the manufacturer (Nutrition Quest) to calculate the baseline iron intake of each subject. Subjects will be enrolled only if they can agree to incorporate the provided pot into their cooking (in any capacity) 3x/week. Subjects will be called 1x/month and asked about the frequency of pot use over the past month as well as their compliance with iron and vitamin C supplements, if prescribed. Subjects will then also be contacted postpartum to determine satisfaction with the intervention.

Outcome measure: We will be looking at hemoglobin levels in the first, second, and third trimester as well as postpartum (which are all routinely collected labs in pregnancy). Ferritin will be added along with routine labs at approximately 19 weeks as this is often performed in the workup of anemia. No labs outside of routine maternal labs will be performed.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • New York Prebyterian Hospital Weill Cornell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pregnant women of any age in their first trimester of pregnancy with anemia defined as a Hemoglobin less than 11 and/or a hematocrit less than 33
• Willingness and ability to cook in provided cast iron pot at least 3x/week
• Singleton gestations

Exclusion Criteria:

• Any secondary cause of anemia including inherited and acquired hemolytic anemias (sickle cell disease, thalessemia, malaria, etc) Inability or unwillingness to try to use cast iron pot approximately 3x/week
• Women with severe chronic illness and high likelihood of preterm birth and/or expected long-term hospitalizations during pregnancy. Multifetal gestations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cast-Iron Pot; The treatment arm will receive a 12 inch pre seasoned cast iron pot	Device: Cast Iron Pot; Cast iron pot; Other Names: Lodge L10SK3 12" Pre-Seasoned Cast Iron Skillet
Placebo Comparator: Aluminum Pot; 12 inch nonstick aluminum fry pan	Device: Alumnium Pot; Aluminum Skillet; Other Names: Alumnium Skillet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Increased hematocrit in second and third trimesters of pregnancy	28 weeks (2nd and 3rd trimesters of pregnancy)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance assessment	We will assess compliance with iron/aluminium pot use at the conclusion of the study	postpartum, after ~30 weeks
Incidence of adverse effects	Will contact patients to assess incidence of adverse effects of iron including constipation	Monthly phone surveys for 28 weeks
Satisfaction	Will contact patient monthly to assess satisfaction with study intervention	Monthly phone surveys for 28 weeks
Maternal anemia postpartum	Will assess subjects need for transfusion and/or symptoms of anemia (dizziness, lightheadedness) postpartum	postpartum, after ~30 weeks
Neonatal outcomes	Will follow up neonatal outcomes to assess for prematurity and/or low birthweight	postpartum, at ~30 weeks

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Stephen Chasen, MD, New York Presbyterian Hospital Weill Cornell

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): July 15, 2020
• Study Completion (Actual): July 15, 2020

Study Registration Dates

• First Submitted: July 30, 2014
• First Submitted That Met QC Criteria: January 13, 2015
• First Posted (Estimate): January 19, 2015

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Pregnancy; Iron-deficiency anemia; Cast-Iron pots
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia; Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: 1310014372

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Deidentified data may be shared. No biologic specimens are being collected in this study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No