Umbilical Cord Clamping and Infant Iron Status - Full Text View

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
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00298051

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	Phase
Iron-Deficiency Anemia	Procedure: Delayed umbilical cord clamping	Phase III

MedlinePlus related topics: Anemia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Umbilical Cord Clamping and Infant Iron Status

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

Estimated Enrollment:	476
Study Start Date:	October 2003
Estimated Study Completion Date:	February 2005

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

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

Locations

Mexico, Distrito Federal
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 of Results:

Chaparro CM, Neufeld LM, Tena Alavez G, Eguia-Liz Cedillo R, Dewey KG. Effect of timing of umbilical cord clamping on iron status in Mexican infants: a randomised controlled trial. Lancet. 2006 Jun 17;367(9527):1997-2004.

Study ID Numbers:	02817-8
Study First Received:	February 28, 2006
Last Updated:	July 17, 2006
ClinicalTrials.gov Identifier:	NCT00298051
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

Study placed in the following topic categories:

Metabolic Diseases
Malnutrition
Hematologic Diseases
Anemia
Nutrition Disorders

Iron Metabolism Disorders
Metabolic disorder
Iron
Deficiency Diseases
Anemia, Iron-Deficiency

Additional relevant MeSH terms:

Anemia, Hypochromic

ClinicalTrials.gov processed this record on January 16, 2009