Umbilical Cord Clamping and Infant Iron Status

May 24, 2017 updated by: University of California, Davis
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

476

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 01090
        • Hospital de Gineco Obstetrica #4 "Luis Castelazo Ayala" del Instituto Mexicano del Seguro Social

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Hematologic status at 6 months of age
Iron status at 6 months of age

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

Instituto Mexicano del Seguro Social
Thrasher Research Fund
Mexican National Institute of Public Health
Fulbright

Investigators

  • Principal Investigator: Lynnette M Neufeld, PhD, Mexican National Institute of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (ACTUAL)

February 1, 2005

Study Completion (ACTUAL)

February 1, 2005

Study Registration Dates

First Submitted

February 28, 2006

First Submitted That Met QC Criteria

February 28, 2006

First Posted (ESTIMATE)

March 1, 2006

Study Record Updates

Last Update Posted (ACTUAL)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02817
  • 02817-8 (OTHER: UC Davis)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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