Clinical trial NCT04594070: Daily Versus Alternate Day Iron Supplementation for the Treatment of Iron Deficiency Anemia in Pregnancy
Official title: A Randomized Trial of Intermittent Oral Iron Supplementation vs. Daily Oral Iron Supplementation for the Treatment of Anemia in Pregnancy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pregnancy Related
Iron Deficiency Anemia of Pregnancy
Keywords: Pregnancy
Iron deficiency
Anemia
Iron supplementation
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in Hemoglobin Levels From Enrollment to End of Study
timeFrame: Baseline and again 8-9 months later (third trimester of pregnancy)
measure: Change in Hematocrit in the Third Trimester After Treatment
timeFrame: Baseline and again 8-9 months later (third trimester of pregnancy)
Secondary outcomes:
measure: Gastrointestinal Side Effects After 2-4 Weeks of Treatment
timeFrame: 2-4 weeks after enrollment
measure: Complete Blood Count in the Third Trimester
timeFrame: 8-9 months after enrollment (third trimester of pregnancy)
measure: Serum Ferritin at Time of Enrollment
timeFrame: Baseline only at time of enrollment
measure: Total Iron Binding Capacity at Time of Enrollment
timeFrame: Baseline only at time of enrollment
measure: Transferrin at Time of Enrollment
timeFrame: Baseline only at time of enrollment
measure: Number of Participants Who Receive Intravenous (IV) Iron Supplementation
timeFrame: At completion of study, on average after 9 months
measure: Number of Participants Who Receive a Blood Transfusion
timeFrame: At completion of study, on average after 9 months
measure: Postpartum Hemoglobin
timeFrame: At completion of study, on average after 9 months
measure: Postpartum Hematocrit
timeFrame: At completion of study, on average after 9 months
measure: Neonatal Weight at Delivery
timeFrame: At completion of study, on average after 9 months
measure: Level of Neonatal Bilirubin at Birth
timeFrame: At completion of study, on average after 9 months
measure: Neonatal Apgar Scores
timeFrame: At completion of study, on average after 9 months
measure: Number of Newborns Who Are Admitted to the Neonatal Intensive Care Unit (NICU).
timeFrame: At completion of study, on average after 9 months
measure: Weight Class at Time of Enrollment
timeFrame: Baseline only at time of enrollment
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: UTMB
name: Melody Safarzadeh, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: