Umbilical Cord Clamping and Infant Iron Status

Iron-deficiency Anemia Clinical Trial

Official title:

Umbilical Cord Clamping and Infant Iron Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00298051
• Other study ID #: 02817
• Secondary ID: 02817-8
• Status: Completed
• Phase: N/A
• First received: February 28, 2006
• Last updated: May 24, 2017
• Start date: October 2003
• Est. completion date: February 2005

Study information

• Verified date: May 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 476
• Est. completion date: February 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron-deficiency Anemia

Intervention

Procedure:
• Delayed umbilical cord clamping

Locations

Country	Name	City	State
Mexico	Hospital de Gineco Obstetrica #4 "Luis Castelazo Ayala" del Instituto Mexicano del Seguro Social	Mexico City	Distrito Federal

Sponsors (5)

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

Country where clinical trial is conducted

Mexico, 

References & Publications (2)

Chaparro CM, Fornes R, Neufeld LM, Tena Alavez G, Eguía-Líz Cedillo R, Dewey KG. Early umbilical cord clamping contributes to elevated blood lead levels among infants with higher lead exposure. J Pediatr. 2007 Nov;151(5):506-12. Epub 2007 Sep 17. — View Citation

Chaparro CM, Neufeld LM, Tena Alavez G, Eguia-Líz 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematologic status at 6 months of age
Primary	Iron status at 6 months of age
Secondary	Maternal report of clinical jaundice at 3 and 14 days of age
Secondary	Newborn hematocrit at 7 hours of age
Secondary	Estimated maternal bleeding at delivery