Umbilical Cord Clamping and Infant Iron Status

University of California, Davis476 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

476

Conditions

Iron-deficiency Anemia

Interventions

Delayed umbilical cord clampingPROCEDURE

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant women delivering at study site hospital Exclusion Criteria: * Delivery by Cesarean section * Pregnancy ≤ 36 or ≥ 42 weeks gestation * Multiple gestation * Diagnosis of any of the following in the current pregnancy: hemorrhage requiring clinic/hospital admission, placental abnormalities, fetal anomalies, Down's syndrome of the fetus * Diagnosis of pre-eclampsia or eclampsia in current or previous pregnancies * Diagnosis at any time for the mother of any of the following: Diabetes, hypertension, cardiopathies, chronic renal disease * Infant with major congenital malformation * Infant birth weight less than 2500 g * Mother not planning to breast feed for at least 6 months * Mother smoked during current pregnancy * Unwilling to return for follow-up study visits at the hospital

Locations (1)

Hospital de Gineco Obstetrica #4 "Luis Castelazo Ayala" del Instituto Mexicano del Seguro Social

Mexico City, Mexico City, Mexico

Outcomes

Primary Outcomes

Hematologic status at 6 months of age

Iron status at 6 months of age

Secondary Outcomes

Maternal report of clinical jaundice at 3 and 14 days of age

Newborn hematocrit at 7 hours of age

Estimated maternal bleeding at delivery

Data from ClinicalTrials.gov

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