Milking the Umbilical Cord at Term Cesarean Birth
1 other identifier
interventional
24
1 country
1
Brief Summary
The purpose of this pilot study is to determine if umbilical cord milking at the time of scheduled cesarean section effects the hemoglobin and hematocrit levels of full-term infants as determined by hemoglobin and hematocrit levels at 36-48 hours of life. This study will help to establish the feasibility of umbilical cord milking as an alternative to delayed clamping at the time of planned cesarean section.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started May 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 26, 2012
CompletedFirst Posted
Study publicly available on registry
June 28, 2012
CompletedOctober 5, 2015
October 1, 2015
11 months
June 26, 2012
October 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Newborn Hemoglobin and Hematocrit levels
At 36-48 hours, term infants (born by planned cesarean section) exposed to umbilical cord milking will have higher hemoglobin and hematocrit levels compared to infants exposed to immediate cord clamping
36-48 hours of life
Secondary Outcomes (1)
Placental Residual Blood Volume
At birth
Study Arms (2)
Umbilical Cord Milking
EXPERIMENTALAt birth, the infant will be held below the level of the placenta and umbilical cord will be milked 5 times after birth and before clamping the cord.
Immediate Cord Clamping
NO INTERVENTIONAt birth, the infant will be held at the level of the placenta and umbilical cord will be clamped within 10 seconds (routine practice).
Interventions
At birth, the infant will be held below the level of the placenta and umbilical cord will be milked 5 times after birth and before clamping the cord.
Eligibility Criteria
You may qualify if:
- Women at full term gestation (37-41 weeks) with:
- Uncomplicated, singleton pregnancy
- English speaking
- Planning an elective Cesarean Section
- Not in labor
You may not qualify if:
- Major medical or obstetrical complications
- Women who smoke
- Intrauterine growth restriction
- Serious congenital anomalies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women & Infants Hospital
Providence, Rhode Island, 02905, United States
Related Publications (1)
Erickson-Owens DA, Mercer JS, Oh W. Umbilical cord milking in term infants delivered by cesarean section: a randomized controlled trial. J Perinatol. 2012 Aug;32(8):580-4. doi: 10.1038/jp.2011.159. Epub 2011 Nov 17.
PMID: 22094494RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Debra Erickson-Owens, PhD, CNM
University of Rhode Island
- PRINCIPAL INVESTIGATOR
Judith Mercer, PhD, CNM
University of Rhode Island and Women & Infants Hospital
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 26, 2012
First Posted
June 28, 2012
Study Start
May 1, 2008
Primary Completion
April 1, 2009
Study Completion
December 1, 2009
Last Updated
October 5, 2015
Record last verified: 2015-10