Umbilical Cord Clamping and Infant Iron Status

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Umbilical Cord Clamping and Infant Iron Status

Conditions
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Iron-deficiency Anemia

Intervention / Treatment
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* Procedure: Delayed umbilical cord clamping


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Early umbilical cord clamping (control)<br>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<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematologic status at 6 months of age |  |  | 
| Iron status at 6 months of age |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal report of clinical jaundice at 3 and 14 days of age |  |  | 
| Newborn hematocrit at 7 hours of age |  |  | 
| Estimated maternal bleeding at delivery |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iron-deficiency anemia, Umbilical cord clamping, Infant