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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04594070
• Other study ID #: 20-0068
• Status: Terminated
• Phase: Phase 4
• Start date: October 27, 2020
• Est. completion date: January 12, 2024

Study information

• Verified date: January 2024
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: January 12, 2024
• Est. primary completion date: January 12, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Iron Deficiency Anemia of Pregnancy
• Pregnancy Related

Intervention

Drug:
• Ferrous sulfate
Iron supplementation

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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
Secondary	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)
Secondary	Serum ferritin at time of enrollment	Serum ferritin will assessed by blood draw at time of enrollment.	Baseline only at time of enrollment
Secondary	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
Secondary	Transferrin at time of enrollment	Transferrin levels will assessed by blood draw at time of enrollment.	Baseline only at time of enrollment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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