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Umbilical Cord Clamping and Infant Iron Status

Umbilical Cord Clamping and Infant Iron Status

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00298051
Enrollment
476
Registered
2006-03-01
Start date
2003-10-31
Completion date
2005-02-28
Last updated
2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron-deficiency Anemia

Keywords

Iron-deficiency anemia, Umbilical cord clamping, Infant

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.

Interventions

Sponsors

Thrasher Research Fund
CollaboratorOTHER
Mexican National Institute of Public Health
CollaboratorOTHER_GOV
Instituto Mexicano del Seguro Social
CollaboratorOTHER_GOV
Fulbright
CollaboratorOTHER
University of California, Davis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Hematologic status at 6 months of age
Iron status at 6 months of age

Secondary

MeasureTime 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

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 11, 2026