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Umbilical Cord Clamping and Infant Iron Status

Primary Purpose

Iron-deficiency Anemia

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Delayed umbilical cord clamping
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Iron-deficiency Anemia focused on measuring Iron-deficiency anemia, Umbilical cord clamping, Infant

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Early umbilical cord clamping (control)

Delayed umbilical cord clamping

Arm Description

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).

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.

Outcomes

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

Full Information

First Posted
February 28, 2006
Last Updated
May 24, 2017
Sponsor
University of California, Davis
Collaborators
Thrasher Research Fund, Mexican National Institute of Public Health, Instituto Mexicano del Seguro Social, Fulbright
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1. Study Identification

Unique Protocol Identification Number
NCT00298051
Brief Title
Umbilical Cord Clamping and Infant Iron Status
Official Title
Umbilical Cord Clamping and Infant Iron Status
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
February 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
Thrasher Research Fund, Mexican National Institute of Public Health, Instituto Mexicano del Seguro Social, Fulbright

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-deficiency Anemia
Keywords
Iron-deficiency anemia, Umbilical cord clamping, Infant

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
476 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early umbilical cord clamping (control)
Arm Type
No Intervention
Arm Description
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).
Arm Title
Delayed umbilical cord clamping
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Delayed umbilical cord clamping
Primary Outcome Measure Information:
Title
Hematologic status at 6 months of age
Title
Iron status at 6 months of age
Secondary Outcome Measure Information:
Title
Maternal report of clinical jaundice at 3 and 14 days of age
Title
Newborn hematocrit at 7 hours of age
Title
Estimated maternal bleeding at delivery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn G Dewey, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lynnette M Neufeld, PhD
Organizational Affiliation
Mexican National Institute of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Gineco Obstetrica #4 "Luis Castelazo Ayala" del Instituto Mexicano del Seguro Social
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
01090
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
16782490
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.
Results Reference
result
PubMed Identifier
17961694
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.
Results Reference
result

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Umbilical Cord Clamping and Infant Iron Status

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