Use of Cast Iron Pots to Improve Maternal Anemia
Primary Purpose
Iron-deficiency Anemia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cast Iron Pot
Alumnium Pot
Sponsored by
About this trial
This is an interventional treatment trial for Iron-deficiency Anemia focused on measuring Pregnancy, Cast-Iron pots, Iron-deficiency anemia
Eligibility Criteria
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
Sites / Locations
- New York Prebyterian Hospital Weill Cornell
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Cast-Iron Pot
Aluminum Pot
Arm Description
The treatment arm will receive a 12 inch pre seasoned cast iron pot
12 inch nonstick aluminum fry pan
Outcomes
Primary Outcome Measures
Increased hematocrit in second and third trimesters of pregnancy
Secondary Outcome Measures
Compliance assessment
We will assess compliance with iron/aluminium pot use at the conclusion of the study
Incidence of adverse effects
Will contact patients to assess incidence of adverse effects of iron including constipation
Satisfaction
Will contact patient monthly to assess satisfaction with study intervention
Maternal anemia postpartum
Will assess subjects need for transfusion and/or symptoms of anemia (dizziness, lightheadedness) postpartum
Neonatal outcomes
Will follow up neonatal outcomes to assess for prematurity and/or low birthweight
Full Information
NCT ID
NCT02341300
First Posted
July 30, 2014
Last Updated
July 28, 2020
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT02341300
Brief Title
Use of Cast Iron Pots to Improve Maternal Anemia
Official Title
Use of Cast Iron Pots to Improve Maternal Anemia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Original investigator has left the institution.
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
July 15, 2020 (Actual)
Study Completion Date
July 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-deficiency Anemia
Keywords
Pregnancy, Cast-Iron pots, Iron-deficiency anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cast-Iron Pot
Arm Type
Experimental
Arm Description
The treatment arm will receive a 12 inch pre seasoned cast iron pot
Arm Title
Aluminum Pot
Arm Type
Placebo Comparator
Arm Description
12 inch nonstick aluminum fry pan
Intervention Type
Device
Intervention Name(s)
Cast Iron Pot
Other Intervention Name(s)
Lodge L10SK3 12" Pre-Seasoned Cast Iron Skillet
Intervention Description
Cast iron pot
Intervention Type
Device
Intervention Name(s)
Alumnium Pot
Other Intervention Name(s)
Alumnium Skillet
Intervention Description
Aluminum Skillet
Primary Outcome Measure Information:
Title
Increased hematocrit in second and third trimesters of pregnancy
Time Frame
28 weeks (2nd and 3rd trimesters of pregnancy)
Secondary Outcome Measure Information:
Title
Compliance assessment
Description
We will assess compliance with iron/aluminium pot use at the conclusion of the study
Time Frame
postpartum, after ~30 weeks
Title
Incidence of adverse effects
Description
Will contact patients to assess incidence of adverse effects of iron including constipation
Time Frame
Monthly phone surveys for 28 weeks
Title
Satisfaction
Description
Will contact patient monthly to assess satisfaction with study intervention
Time Frame
Monthly phone surveys for 28 weeks
Title
Maternal anemia postpartum
Description
Will assess subjects need for transfusion and/or symptoms of anemia (dizziness, lightheadedness) postpartum
Time Frame
postpartum, after ~30 weeks
Title
Neonatal outcomes
Description
Will follow up neonatal outcomes to assess for prematurity and/or low birthweight
Time Frame
postpartum, at ~30 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Chasen, MD
Organizational Affiliation
New York Presbyterian Hospital Weill Cornell
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Prebyterian Hospital Weill Cornell
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Deidentified data may be shared. No biologic specimens are being collected in this study
Learn more about this trial
Use of Cast Iron Pots to Improve Maternal Anemia
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