Effect of Infant Placement on Iron Stores in Infancy: A Pilot Study

Davison, James, D.O.30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Iron Deficiency Anemia

Interventions

perineum maintainedPROCEDURE

infants maintained at the level of the perineum until umbilical cord clamping

abdominal placementPROCEDURE

infants placed on the maternal abdomen prior to umbilical cord clamping

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

serum ferritin level at 4 months of age

Time frame: 4 months

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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