Umbilical Cord Clamping and Infant Iron Status

Not Applicable

Completed

• Conditions: Iron-deficiency Anemia
• Interventions: Procedure: Delayed umbilical cord clamping

• Registration Number: NCT00298051
• Lead Sponsor: University of California, Davis

Brief Summary

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

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 Timeline

• Study Start: 2003-10
• Primary Completion: 2005-02
• Study Completion: 2005-02
• Study First Submitted: 2006-02-28
• Study First Submitted QC: 2006-02-28
• Study First Posted: 2006-03-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 476

Inclusion Criteria

• Pregnant women delivering at study site hospital

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed umbilical cord clamping	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.

Primary Outcome Measures

Name	Time	Method
Hematologic status at 6 months of age
Iron status at 6 months of age

Secondary Outcome Measures

Name	Time	Method
Newborn hematocrit at 7 hours of age
Maternal report of clinical jaundice at 3 and 14 days of age
Estimated maternal bleeding at delivery

Trial Locations

Locations (1)

Hospital de Gineco Obstetrica #4 "Luis Castelazo Ayala" del Instituto Mexicano del Seguro Social; 🇲🇽 Mexico City, Distrito Federal, Mexico