Effect of Infant Placement on Iron Stores in Infancy: A Pilot Study
This trial is active, not recruiting.
|Conditions||iron deficiency, anemia|
|Treatments||perineum maintained, abdominal placement|
|Sponsor||Davison, James, D.O.|
|Start date||June 2008|
|End date||December 2008|
|Trial size||30 participants|
|Trial identifier||NCT00675337, wghjmd1|
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.
|Endpoint classification||safety study|
|Intervention model||parallel assignment|
|Masking||single blind (caregiver)|
serum ferritin level at 4 months of age
time frame: 4 months
blood parameters (hemoglobin and hematocrit)
time frame: 2 months and 4 months
serum ferritin at 2 months
time frame: 2 months
blood parameters (hemoglobin and hematocrit) at 24 hrs of age
time frame: 24 hrs.
Female participants of any age.
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
|Official title||The Effect of Infant Placement at Delivery on Iron Stores in Early Infancy: A Pilot Study|
|Principal investigator||James M Davison, DO|
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