Daily vs Intermittent Iron Therapy in Pregnancy
Completed · Not applicable
Conditions studied: Iron Deficiency Anemia of Pregnancy
In brief
This is a randomized non inferiority trial to evaluate the response to iron therapy in the standard daily vs. intermittent (three-four times a week on nonconsecutive days) groups by using hematological markers (hemoglobin, hematocrit, transferrin, hepcidin, ferritin, human soluble transferrin receptor). The secondary outcome is to evaluate gastrointestinal discomfort and adherence to therapy between two treatment groups.
Key facts
- Study ID
- NCT03706638
- Run by
- UConn Health
- People needed
- 46
- Starts
- 2018-10-25
- Expected to finish
- 2020-03-23
- Last updated by the study team
- 2020-04-21
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Pregnant women who are not underweight (BMI < 18.5 kg/m2)
- Reproductive-aged women 18-50
- Singleton Pregnancy.
- Patients undergoing third trimester blood work from 26-28 weeks.
- Women who have had previously normal first-trimester blood work (hemoglobin, hematocrit, MCV) without any evidence of existing anemia.
- Pregnant women with anemia designated with hemoglobin concentration less than 11 g/dL or hematocrit less than 33%
- No pre-existing iron deficiency anemia or not already on iron supplementation.
You may not qualify if…
- Women with medical problems known to affect iron metabolism or homeostasis
- Women with existing thalassemias or anemias.
- Women with abnormal bloodwork indicating anemia earlier in the pregnancy.
- Women are already taking iron supplementation during the pregnancy for treatment of iron deficiency anemia.
- Chronic illness is influencing iron absorption.
- Underlying malabsorption disease.
- History of bariatric surgery.
- Severe anemia with maternal hemoglobin levels less than 6 g/dL
- Preterm Labor, PPROM, signs of infection.
Where it is running
- UConn Health — Farmington, Connecticut, United States
Full record on ClinicalTrials.gov
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