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

Phase 4

Terminated

Conditions: Pregnancy Related
Iron Deficiency Anemia of Pregnancy

Interventions: Drug: Ferrous sulfate

Registration Number: NCT04594070

Lead Sponsor: The University of Texas Medical Branch, Galveston

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 14

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daily iron supplementation	Ferrous sulfate	Oral ferrous sulfate, 325 mg, take once daily
Alternate day iron supplementation	Ferrous sulfate	Oral ferrous sulfated, 650mg, taken once daily every other day

Primary Outcome Measures

Name	Time	Method
Difference in Hemoglobin Levels From Enrollment to End of Study	Baseline and again 8-9 months later (third trimester of pregnancy)	Hemoglobin levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy
Change in Hematocrit in the Third Trimester After Treatment	Baseline and again 8-9 months later (third trimester of pregnancy)	Hematocrit levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal Side Effects After 2-4 Weeks of Treatment	2-4 weeks after enrollment	Gastrointestinal side effects with treatment will be assessed by telephone survey using a validated questionnaire.
Number of Participants Who Receive Intravenous (IV) Iron Supplementation	At completion of study, on average after 9 months	By chart review, we will determine if the subject received parental (IV) iron supplementation as part of the treatment for iron deficiency anemia
Postpartum Hematocrit	At completion of study, on average after 9 months	Hematocrit levels after delivery will be recorded (if obtained as part of regular postpartum care)
Neonatal Apgar Scores	At completion of study, on average after 9 months	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.
Weight Class at Time of Enrollment	Baseline only 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
Total Iron Binding Capacity at Time of Enrollment	Baseline only at time of enrollment	Total iron binding capacity will assessed by blood draw at time of enrollment.
Number of Newborns Who Are Admitted to the Neonatal Intensive Care Unit (NICU).	At completion of study, on average after 9 months	The need for Neonatal Intensive Care Unit (NICU) Admission, will be assessed
Complete Blood Count in the Third Trimester	8-9 months after enrollment (third trimester of pregnancy)	Complete blood count indices will be assessed by blood draw upon enrollment and approximately monthly until delivery
Serum Ferritin at Time of Enrollment	Baseline only at time of enrollment	Serum ferritin will assessed by blood draw at time of enrollment.
Transferrin at Time of Enrollment	Baseline only at time of enrollment	Transferrin levels will assessed by blood draw at time of enrollment.
Number of Participants Who Receive a Blood Transfusion	At completion of study, on average after 9 months	By chart review, we will determine if the subject received a blood transfusion as part of the treatment for iron deficiency anemia
Level of Neonatal Bilirubin at Birth	At completion of study, on average after 9 months	Neonatal hyperbilirubinemia will be reviewed and recorded by chart review
Postpartum Hemoglobin	At completion of study, on average after 9 months	Hemoglobin levels after delivery will be recorded (if obtained as part of regular postpartum care)
Neonatal Weight at Delivery	At completion of study, on average after 9 months	The weight of the baby (in grams) will be determined by chart review at the end of enrollment