Trial Outcomes & Findings for Daily Versus Alternate Day Iron Supplementation for the Treatment of Iron Deficiency Anemia in Pregnancy (NCT NCT04594070)
NCT ID: NCT04594070
Last Updated: 2024-06-24
Results Overview
Hemoglobin levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy
TERMINATED
PHASE4
14 participants
Baseline and again 8-9 months later (third trimester of pregnancy)
2024-06-24
Participant Flow
The protocol was terminated early due to low accrual.
Participant milestones
| Measure |
Daily Iron Supplementation
Oral ferrous sulfate, 325 mg, take once daily
Ferrous sulfate: Iron supplementation
|
Alternate Day Iron Supplementation
Oral ferrous sulfated, 650mg, taken once daily every other day
Ferrous sulfate: Iron supplementation
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Daily Versus Alternate Day Iron Supplementation for the Treatment of Iron Deficiency Anemia in Pregnancy
Baseline characteristics by cohort
| Measure |
Daily Iron Supplementation
n=8 Participants
Oral ferrous sulfate, 325 mg, take once daily
Ferrous sulfate: Iron supplementation
|
Alternate Day Iron Supplementation
n=6 Participants
Oral ferrous sulfated, 650mg, taken once daily every other day
Ferrous sulfate: Iron supplementation
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and again 8-9 months later (third trimester of pregnancy)Population: No data collected due to early termination.
Hemoglobin levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and again 8-9 months later (third trimester of pregnancy)Population: No data collected due to early termination.
Hematocrit levels will be assessed by blood draw upon enrollment and again in the third trimester of pregnancy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2-4 weeks after enrollmentPopulation: No data collected due to early termination.
Gastrointestinal side effects with treatment will be assessed by telephone survey using a validated questionnaire.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8-9 months after enrollment (third trimester of pregnancy)Population: No data collected due to early termination.
Complete blood count indices will be assessed by blood draw upon enrollment and approximately monthly until delivery
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline only at time of enrollmentPopulation: No data collected due to early termination.
Serum ferritin will assessed by blood draw at time of enrollment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline only at time of enrollmentPopulation: No data collected due to early termination.
Total iron binding capacity will assessed by blood draw at time of enrollment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline only at time of enrollmentPopulation: No data collected due to early termination.
Transferrin levels will assessed by blood draw at time of enrollment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At completion of study, on average after 9 monthsPopulation: No data collected due to early termination.
By chart review, we will determine if the subject received parental (IV) iron supplementation as part of the treatment for iron deficiency anemia
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At completion of study, on average after 9 monthsPopulation: No data collected due to early termination.
By chart review, we will determine if the subject received a blood transfusion as part of the treatment for iron deficiency anemia
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At completion of study, on average after 9 monthsPopulation: No data collected due to early termination.
Hemoglobin levels after delivery will be recorded (if obtained as part of regular postpartum care)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At completion of study, on average after 9 monthsPopulation: No data collected due to early termination.
Hematocrit levels after delivery will be recorded (if obtained as part of regular postpartum care)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At completion of study, on average after 9 monthsPopulation: No data collected due to early termination.
The weight of the baby (in grams) will be determined by chart review at the end of enrollment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At completion of study, on average after 9 monthsPopulation: No data collected due to early termination.
Neonatal hyperbilirubinemia will be reviewed and recorded by chart review
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At completion of study, on average after 9 monthsPopulation: No data collected due to early termination.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At completion of study, on average after 9 monthsPopulation: No data collected due to early termination.
The need for Neonatal Intensive Care Unit (NICU) Admission, will be assessed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline only at time of enrollmentPopulation: No data collected due to early termination.
At time of enrollment the weight of the subject will be assessed and assigned a weight class using the World Health Organization weight classification
Outcome measures
Outcome data not reported
Adverse Events
Daily Iron Supplementation
Alternate Day Iron Supplementation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Melody Safarzadeh
University of Texas Medical Branch Galveston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place