Use of Cast Iron Pots to Improve Maternal Anemia

Iron-deficiency Anemia Clinical Trial

Official title:

Use of Cast Iron Pots to Improve Maternal Anemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02341300
• Other study ID #: 1310014372
• Status: Terminated
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: July 15, 2020

Study information

• Verified date: July 2020
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: July 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron-deficiency Anemia

Intervention

Device:
• Cast Iron Pot
Cast iron pot
• Alumnium Pot
Aluminum Skillet

Locations

Country	Name	City	State
United States	New York Prebyterian Hospital Weill Cornell	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increased hematocrit in second and third trimesters of pregnancy		28 weeks (2nd and 3rd trimesters of pregnancy)
Secondary	Compliance assessment	We will assess compliance with iron/aluminium pot use at the conclusion of the study	postpartum, after ~30 weeks
Secondary	Incidence of adverse effects	Will contact patients to assess incidence of adverse effects of iron including constipation	Monthly phone surveys for 28 weeks
Secondary	Satisfaction	Will contact patient monthly to assess satisfaction with study intervention	Monthly phone surveys for 28 weeks
Secondary	Maternal anemia postpartum	Will assess subjects need for transfusion and/or symptoms of anemia (dizziness, lightheadedness) postpartum	postpartum, after ~30 weeks
Secondary	Neonatal outcomes	Will follow up neonatal outcomes to assess for prematurity and/or low birthweight	postpartum, at ~30 weeks