Iron Deficiency Anemia of Pregnancy, Pregnancy Related
Conditions
Keywords
Pregnancy, Iron deficiency, Anemia, Iron supplementation
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.
Interventions
DRUGFerrous sulfate
Iron supplementation
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Serum Ferritin at Time of Enrollment | Baseline only at time of enrollment | Serum ferritin will assessed by blood draw at time of enrollment. |
| 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. |
| 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 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 |
| 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 |
| 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) |
| 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. |
| 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 |
| 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 |
| 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. |
| 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 |
| 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 |
| 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) |
| 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 |
Countries
United States
Participant flow
Pre-assignment details
The protocol was terminated early due to low accrual.
Participants by arm
| Arm | Count |
|---|---|
| Daily Iron Supplementation Oral ferrous sulfate, 325 mg, take once daily
Ferrous sulfate: Iron supplementation | 8 |
| Alternate Day Iron Supplementation Oral ferrous sulfated, 650mg, taken once daily every other day
Ferrous sulfate: Iron supplementation | 6 |
| Total | 14 |
Baseline characteristics
| Characteristic | Daily Iron Supplementation | Alternate Day Iron Supplementation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 6 Participants | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 2 Participants | 5 Participants |
| Region of Enrollment United States | 8 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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
Time frame: Baseline and again 8-9 months later (third trimester of pregnancy)
Population: No data collected due to early termination.
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
Time frame: Baseline and again 8-9 months later (third trimester of pregnancy)
Population: No data collected due to early termination.
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
Time frame: 8-9 months after enrollment (third trimester of pregnancy)
Population: No data collected due to early termination.
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.
Time frame: 2-4 weeks after enrollment
Population: No data collected due to early termination.
Secondary
Level of Neonatal Bilirubin at Birth
Neonatal hyperbilirubinemia will be reviewed and recorded by chart review
Time frame: At completion of study, on average after 9 months
Population: No data collected due to early termination.
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.
Time frame: At completion of study, on average after 9 months
Population: No data collected due to early termination.
Secondary
Neonatal Weight at Delivery
The weight of the baby (in grams) will be determined by chart review at the end of enrollment
Time frame: At completion of study, on average after 9 months
Population: No data collected due to early termination.
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
Time frame: At completion of study, on average after 9 months
Population: No data collected due to early termination.
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
Time frame: At completion of study, on average after 9 months
Population: No data collected due to early termination.
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
Time frame: At completion of study, on average after 9 months
Population: No data collected due to early termination.
Secondary
Postpartum Hematocrit
Hematocrit levels after delivery will be recorded (if obtained as part of regular postpartum care)
Time frame: At completion of study, on average after 9 months
Population: No data collected due to early termination.
Secondary
Postpartum Hemoglobin
Hemoglobin levels after delivery will be recorded (if obtained as part of regular postpartum care)
Time frame: At completion of study, on average after 9 months
Population: No data collected due to early termination.
Secondary
Serum Ferritin at Time of Enrollment
Serum ferritin will assessed by blood draw at time of enrollment.
Time frame: Baseline only at time of enrollment
Population: No data collected due to early termination.
Secondary
Total Iron Binding Capacity at Time of Enrollment
Total iron binding capacity will assessed by blood draw at time of enrollment.
Time frame: Baseline only at time of enrollment
Population: No data collected due to early termination.
Secondary
Transferrin at Time of Enrollment
Transferrin levels will assessed by blood draw at time of enrollment.
Time frame: Baseline only at time of enrollment
Population: No data collected due to early termination.
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
Time frame: Baseline only at time of enrollment
Population: No data collected due to early termination.