Umbilical Cord Clamping and Infant Iron Status

This study has been completed.
Sponsor:
Collaborators:
Thrasher Research Fund
Mexican National Institute of Public Health
Instituto Mexicano del Seguro Social
U.S. Fulbright Program
Information provided by (Responsible Party):
Kathryn Dewey, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00298051
First received: February 28, 2006
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Iron-deficiency Anemia
Procedure: Delayed umbilical cord clamping

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Umbilical Cord Clamping and Infant Iron Status

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Hematologic status at 6 months of age
  • Iron status at 6 months of age

Secondary Outcome Measures:
  • Maternal report of clinical jaundice at 3 and 14 days of age
  • Newborn hematocrit at 7 hours of age
  • Estimated maternal bleeding at delivery

Enrollment: 476
Study Start Date: October 2003
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Early umbilical cord clamping (control)
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
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00298051

Locations
Mexico
Hospital de Gineco Obstetrica #4 "Luis Castelazo Ayala" del Instituto Mexicano del Seguro Social
Mexico City, Distrito Federal, Mexico, 01090
Sponsors and Collaborators
University of California, Davis
Thrasher Research Fund
Mexican National Institute of Public Health
Instituto Mexicano del Seguro Social
U.S. Fulbright Program
Investigators
Principal Investigator: Kathryn G Dewey, PhD University of California, Davis
Principal Investigator: Lynnette M Neufeld, PhD Mexican National Institute of Public Health
  More Information

Publications:
Responsible Party: Kathryn Dewey, Principal Investigator, University of California, Davis
ClinicalTrials.gov Identifier: NCT00298051     History of Changes
Other Study ID Numbers: 02817-8
Study First Received: February 28, 2006
Last Updated: September 26, 2013
Health Authority: United States: Institutional Review Board
Mexico: National Institute of Public Health, Health Secretariat
Mexico: Mexican Institute of Social Security

Keywords provided by University of California, Davis:
Iron-deficiency anemia
Umbilical cord clamping
Infant

Additional relevant MeSH terms:
Anemia
Deficiency Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 26, 2014