Anemia, Iron Deficiency
Conditions
Keywords
iron stores, anemia, iron deficiency, infancy, placental transfusion, iron deficiency in infancy, anemia in infancy, placement of neonate
Brief summary
This is a pilot study designed to assess the safety of placing an infant on the mother's abdomen at the time of delivery, prior to clamping the umbilical cord and the effect of placing the infant on the mother's abdomen on the infant's iron stores. It is possible that placing the infant on the mother's abdomen (above the placenta) may lower the infant's iron stores during early infancy.
Interventions
PROCEDUREperineum maintained
infants maintained at the level of the perineum until umbilical cord clamping
PROCEDUREabdominal placement
infants placed on the maternal abdomen prior to umbilical cord clamping
Sponsors
Davison, James, D.O.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* healthy pregnant women * 37 - 42 weeks of gestation * vaginal delivery * prenatal care initiated prior to 20 weeks of gestation
Exclusion criteria
* maternal diabetes * intrauterine growth restriction * hypertensive disorders of pregnancy * chronic hypertension requiring medical therapy * Apgar score less than 7 at 5 minutes * unusual bleeding prior to delivery * alloimmunization * maternal hemoglobinopathy * need for immediate infant resuscitation preventing adherence to protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum ferritin level at 4 months of age | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| blood parameters (hemoglobin and hematocrit) | 2 months and 4 months |
| serum ferritin at 2 months | 2 months |
| blood parameters (hemoglobin and hematocrit) at 24 hrs of age | 24 hrs. |
Outcome results
None listed