Clinical trial NCT00298051: Umbilical Cord Clamping and Infant Iron Status
Official title: Umbilical Cord Clamping and Infant Iron Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron-deficiency Anemia
Keywords: Iron-deficiency anemia
Umbilical cord clamping
Infant
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
name: Mexican National Institute of Public Health
name: Instituto Mexicano del Seguro Social
name: Fulbright
First posted: 2006-03-01
Enrollment: 476
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Hematologic status at 6 months of age
measure: Iron status at 6 months of age
Secondary outcomes:
measure: Maternal report of clinical jaundice at 3 and 14 days of age
measure: Newborn hematocrit at 7 hours of age
measure: Estimated maternal bleeding at delivery
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital de Gineco Obstetrica #4 "Luis Castelazo Ayala" del Instituto Mexicano del Seguro Social
state: Distrito Federal
Study officials:
affiliation: University of California, Davis
name: Kathryn G Dewey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mexican National Institute of Public Health
name: Lynnette M Neufeld, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/S0140-6736(06)68889-2.
citation: Chaparro CM, Fornes R, Neufeld LM, Tena Alavez G, Eguia-Liz 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. doi: 10.1016/j.jpeds.2007.04.056. Epub 2007 Sep 17.