Use of Cast Iron Pots to Improve Maternal Anemia

NCT02341300 | Terminated

• 1 other identifier: 1310014372
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Iron-deficiency Anemia

Keywords

Pregnancy; Cast-Iron pots; Iron-deficiency anemia

Outcome Measures

Primary Outcomes (1)

• Increased hematocrit in second and third trimesters of pregnancy

  28 weeks (2nd and 3rd trimesters of pregnancy)

Secondary Outcomes (5)

• Compliance assessment

  postpartum, after ~30 weeks

• Incidence of adverse effects

  Monthly phone surveys for 28 weeks

• Satisfaction

  Monthly phone surveys for 28 weeks

• Maternal anemia postpartum

  postpartum, after ~30 weeks

• Neonatal outcomes

  postpartum, at ~30 weeks

Study Arms (2)

Cast-Iron Pot

EXPERIMENTAL

The treatment arm will receive a 12 inch pre seasoned cast iron pot

Device: Cast Iron Pot

Aluminum Pot

PLACEBO COMPARATOR

12 inch nonstick aluminum fry pan

Device: Alumnium Pot

Interventions

Cast Iron Pot DEVICE

Cast iron pot

Also known as: Lodge L10SK3 12" Pre-Seasoned Cast Iron Skillet

Cast-Iron Pot

Alumnium Pot DEVICE

Aluminum Skillet

Also known as: Alumnium Skillet

Aluminum Pot

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

New York Prebyterian Hospital Weill Cornell

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Stephen Chasen, MD

  New York Presbyterian Hospital Weill Cornell

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2014
• First Posted: January 19, 2015
• Study Start: July 15, 2020
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: July 30, 2020

Record last verified: 2020-07

Locations

US (1)