Placental Transfusion in Term Infants: A Pilot Study
1 other identifier
interventional
32
1 country
1
Brief Summary
The proposed study is a pilot prospective controlled trial to measure the blood volume left in the placenta after varying cord clamping times when the infant is placed skin-to-skin on the maternal abdomen. Delaying cord clamping has been shown to decrease anemia in infants. However, the best way to get the most blood to the baby is not known. The practice of cord clamping at birth is not the same among doctors and midwives and we do not know the effect of putting he baby on the mother's abdomen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2010
Shorter than P25 for not_applicable
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
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 14, 2013
CompletedFirst Posted
Study publicly available on registry
August 16, 2013
CompletedAugust 16, 2013
August 1, 2013
6 months
August 14, 2013
August 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Placental Residual Blood volume
Blood remaining in the placenta after cord clamping measured by drainage
obtained immediately after birth
Secondary Outcomes (1)
Infant hematocrit and hemoglobin
at 36 to 48 hours of age
Other Outcomes (1)
serum bilirubin
at 36 to 48 hours of age
Study Arms (4)
Immediate cord clamping
NO INTERVENTIONprovider clamps and cuts the cord within 10 seconds after birth
cord clamping at 2 minutes
EXPERIMENTALProvider places infant on maternal abdomen and cuts cord at 2 minutes after birth
cord clamping at 5 minutes
EXPERIMENTALProvider places the infant on maternal abdomen and clamps and cuts cord at 5 minutes
cord milking
EXPERIMENTALprovider milks the cord 5 times from placenta to infant
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women & Infants Hospital
Providence, Rhode Island, 02905, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Judith S Mercer, PhD, CNM
University of Rhode Island
- STUDY DIRECTOR
Debra A Erickson-owens, PhD, CNM
University of Rhode Island
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Principal Investigator
Study Record Dates
First Submitted
August 14, 2013
First Posted
August 16, 2013
Study Start
July 1, 2010
Primary Completion
January 1, 2011
Study Completion
May 1, 2011
Last Updated
August 16, 2013
Record last verified: 2013-08