Umbilical Cord Clamping and Infant Iron Status

University of California (UC) Davis

Status: Completed

Conditions: Iron-deficiency Anemia

Treatments: Procedure: Delayed umbilical cord clamping

Study type: Interventional

Funder types: Other

Identifiers

NCT00298051

02817

02817-8 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 476 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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476 participants in 2 patient groups

Early umbilical cord clamping (control)

No Intervention group

Description:

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).

Delayed umbilical cord clamping

Experimental group

Description:

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.

Treatment:

Procedure: Delayed umbilical cord clamping