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Completed

NCT Number: NCT00298051

Umbilical Cord Clamping and Infant Iron Status

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Mexico City, 01090, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Delayed umbilical cord clamping

Procedure

Primary outcomes

  1. Hematologic status at 6 months of age

  2. Iron status at 6 months of age

Secondary outcomes

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

  2. Newborn hematocrit at 7 hours of age

  3. Estimated maternal bleeding at delivery

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Fulbright
  • Instituto Mexicano del Seguro Social
  • Mexican National Institute of Public Health
  • Thrasher Research Fund

Registry information

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Mar 1, 2006
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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