NCT00298051

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
476

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2006

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

February 28, 2006

Last Update Submit

May 24, 2017

Conditions

Iron-deficiency Anemia

Keywords

Iron-deficiency anemiaUmbilical cord clampingInfant

Outcome Measures

Primary Outcomes (2)

  • Hematologic status at 6 months of age

  • Iron status at 6 months of age

Secondary Outcomes (3)

  • Maternal report of clinical jaundice at 3 and 14 days of age

  • Newborn hematocrit at 7 hours of age

  • Estimated maternal bleeding at delivery

Study Arms (2)

Early umbilical cord clamping (control)

NO INTERVENTION

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).

Delayed umbilical cord clamping

EXPERIMENTAL

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

Interventions

Delayed umbilical cord clampingPROCEDURE
Delayed umbilical cord clamping

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women delivering at study site hospital

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Mexico City, Mexico City, 01090, Mexico

Location

Related Publications (2)

  • 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.

    PMID: 16782490RESULT

  • 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.

    PMID: 17961694RESULT

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Kathryn G Dewey, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

  • Lynnette M Neufeld, PhD

    Mexican National Institute of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2006

First Posted

March 1, 2006

Study Start

October 1, 2003

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

ME(1)