Umbilical Cord Clamping and Infant Iron Status
The aim of the study was to determine whether delayed umbilical cord clamping, as compared to early umbilical cord clamping, improves infant iron status at 6 months of age.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Umbilical Cord Clamping and Infant Iron Status|
- Hematologic status at 6 months of age
- Iron status at 6 months of age
- Maternal report of clinical jaundice at 3 and 14 days of age
- Newborn hematocrit at 7 hours of age
- Estimated maternal bleeding at delivery
|Study Start Date:||October 2003|
|Study Completion Date:||February 2005|
|Primary Completion Date:||February 2005 (Final data collection date for primary outcome measure)|
No Intervention: Early umbilical cord clamping (control)
Umbilical cord was clamped immediately, or as close as possible, after delivery of the infant's shoulders. (This was standard practice in the study hospital, thus it served as the "control" group).
Experimental: Delayed umbilical cord clamping
Umbilical cord was clamped at 2 minutes after delivery of the infant's shoulder's with the infant held at the level of the mother's uterus.
|Procedure: Delayed umbilical cord clamping|
In developing countries, up to 50% of children become anemic by 12 months of age. Risk factors for iron deficiency (ID) include low birth weight, maternal prenatal ID, and male sex. Iron deficiency anemia (IDA) during infancy and childhood is of particular concern because of the potentially detrimental effects on development, some of which may be irreversible even after treatment to correct the deficiency. Delayed umbilical cord clamping is an intervention that increases the infant's iron endowment at birth and has been shown to increase hemoglobin (Hgb) concentration at two months of age. We determined whether a two-minute delay in the clamping of the umbilical cord of normal-weight, full-term infants significantly affected infant iron and hematological status through 6 months of age. In addition, we determined whether the effect of delayed cord clamping was significantly enhanced in subgroups of infants at higher risk of developing iron deficiency.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298051
|Hospital de Gineco Obstetrica #4 "Luis Castelazo Ayala" del Instituto Mexicano del Seguro Social|
|Mexico City, Distrito Federal, Mexico, 01090|
|Principal Investigator:||Kathryn G Dewey, PhD||University of California, Davis|
|Principal Investigator:||Lynnette M Neufeld, PhD||Mexican National Institute of Public Health|