Overview

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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking single blind (caregiver)
Primary purpose prevention
Arm
(Active Comparator)
infants maintained at the level of the perineum until umbilical cord clamping
perineum maintained
infants maintained at the level of the perineum until umbilical cord clamping
(Experimental)
infants placed on the maternal abdomen prior to cord clamping
abdominal placement
infants placed on the maternal abdomen prior to umbilical cord clamping

Primary Outcomes

Measure
serum ferritin level at 4 months of age
time frame: 4 months

Secondary Outcomes

Measure
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.

Eligibility Criteria

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

Additional Information

Official title The Effect of Infant Placement at Delivery on Iron Stores in Early Infancy: A Pilot Study
Principal investigator James M Davison, DO
Trial information was received from ClinicalTrials.gov and was last updated in December 2008.
Information provided to ClinicalTrials.gov by Davison, James, D.O..