Daily Versus Alternate Day Iron Supplementation for the Treatment of Iron Deficiency Anemia in Pregnancy

Study Overview
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Brief Summary
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The target population for our study is pregnant women in the first or second trimester with a diagnosis of iron deficiency anemia. If a subject is eligible, written consent will be obtained by person to person contact. Eligible participants will be randomized to receive either daily oral iron supplementation or every other day oral iron supplementation.

Detailed Description
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Eligible pregnant women in the first or second trimester who carry a diagnosis of iron deficiency anemia as defined by the American College of Obstetrics and Gynecology will be approached, consented, and randomized to receive either daily oral ferrous sulfate (325mg) supplementation or every other day oral ferrous sulfate (650mg). Participants will undergo a phone survey 2-4 weeks after starting the study to assess for side effects. Participants will continue routine care and surveillance of iron deficiency in pregnancy until the end of pregnancy.

Official Title
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A Randomized Trial of Intermittent Oral Iron Supplementation vs. Daily Oral Iron Supplementation for the Treatment of Anemia in Pregnancy

Conditions
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Pregnancy Related, Iron Deficiency Anemia of Pregnancy

Intervention / Treatment
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* Drug: Ferrous sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemoglobin less than 11 g/dl in the first trimester or less than 10.5 g/dl in the second trimester Microcytic anemia Singleton gestation in the first or second trimester Exclusion Criteria: Malabsorptive disorder or history of restrictive or malabsorptive gastric surgery Known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic, sickle cell, etc.) History of cardiopulmonary disease Severe anemia requiring parental infusion or transfusion of blood products

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Daily iron supplementation<br>Oral ferrous sulfate, 325 mg, take once daily | Drug: Ferrous sulfate<br>* Iron supplementation<br>|
| Experimental: Alternate day iron supplementation<br>Oral ferrous sulfated, 650mg, taken once daily every other day | Drug: Ferrous sulfate<br>* Iron supplementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in hemoglobin levels from enrollment to end of study | Hemoglobin levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy | Baseline and again 8-9 months later (third trimester of pregnancy) | 
| Change in hematocrit in the third trimester after treatment | Hematocrit levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy | Baseline and again 8-9 months later (third trimester of pregnancy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal side effects after 2-4 weeks of treatment | Gastrointestinal side effects with treatment will be assessed by telephone survey using a validated questionnaire. | 2-4 weeks after enrollment | 
| Complete blood count in the third trimester | Complete blood count indices will be assessed by blood draw upon enrollment and approximately monthly until delivery | 8-9 months after enrollment (third trimester of pregnancy) | 
| Serum ferritin at time of enrollment | Serum ferritin will assessed by blood draw at time of enrollment. | Baseline only at time of enrollment | 
| Total iron binding capacity at time of enrollment | Total iron binding capacity will assessed by blood draw at time of enrollment. | Baseline only at time of enrollment | 
| Transferrin at time of enrollment | Transferrin levels will assessed by blood draw at time of enrollment. | Baseline only at time of enrollment | 
| Number of participants who receive intravenous (IV) iron supplementation | By chart review, we will determine if the subject received parental (IV) iron supplementation as part of the treatment for iron deficiency anemia | At completion of study, on average after 9 months | 
| Number of participants who receive a blood transfusion | By chart review, we will determine if the subject received a blood transfusion as part of the treatment for iron deficiency anemia | At completion of study, on average after 9 months | 
| Postpartum hemoglobin | Hemoglobin levels after delivery will be recorded (if obtained as part of regular postpartum care) | At completion of study, on average after 9 months | 
| Postpartum hematocrit | Hematocrit levels after delivery will be recorded (if obtained as part of regular postpartum care) | At completion of study, on average after 9 months | 
| Neonatal weight at delivery | The weight of the baby (in grams) will be determined by chart review at the end of enrollment | At completion of study, on average after 9 months | 
| Level of neonatal bilirubin at birth | Neonatal hyperbilirubinemia will be reviewed and recorded by chart review | At completion of study, on average after 9 months | 
| Neonatal Apgar scores | Neonatal Apgar scores will be reviewed and recorded by chart review. The Apgar score is a method used to describe a newborn's status at birth and response to resuscitation. The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. The range of scores is 0 to 10. Higher scores indicate reassuring newborn status. | At completion of study, on average after 9 months | 
| Number of newborns who are admitted to the Neonatal Intensive Care Unit (NICU). | The need for Neonatal Intensive Care Unit (NICU) Admission, will be assessed | At completion of study, on average after 9 months | 
| Weight class at time of enrollment | At time of enrollment the weight of the subject will be assessed and assigned a weight class using the World Health Organization weight classification | Baseline only at time of enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Iron deficiency, Anemia, Iron supplementation