- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01523769
Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants
January 30, 2012 updated by: Eastern Virginia Medical School
The Efficacy of Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants Born Between 24 and 28 6/7 Weeks Gestation, a Randomized Controlled Trial.
Delayed cord clamp of at least 30 seconds in neonates under 37 weeks has shown that these infants have higher circulating blood volume in the first 24 hours, less need for blood transfusions, and less incidence of intraventricular hemorrhage.
Delayed umbilical cord clamping has also been shown to increase the initial hematocrit and decrease the need for red blood cell (RBC) transfusions compared with no intervention in infants born between 27 and 33 weeks' gestation.
However, a delay in cord clamping of 30-45 seconds may theoretically interfere with neonatal resuscitation.
There have been few studies that addressed the active milking of the cord and its effect on neonatal resuscitation.
Active milking of the umbilical cord towards the baby prior to clamping (rather than passive) should take less than 5 seconds to perform and should not interfere with neonatal resuscitation.
Umbilical cord milking, as an alternative to delayed cord clamping, has been shown to increase the circulatory blood volume expressed as the hemoglobin value.
Active milking of the cord prior to clamping, however, is not considered standard of care and only 1 Japanese randomized control study has reported that umbilical cord milking reduces the need for RBC transfusions, thus reducing the number of infants requiring a RBC transfusion as compared with control conditions.
Our study aims to test the hypothesis that active milking of the umbilical cord will reduce the need for transfusion in preterm infants.
Study Overview
Detailed Description
The proposed design is a randomized controlled trial.
Pregnant women at risk for delivering a singleton preterm infant between 24 and 28 weeks gestation will be randomized prior to delivery into one of two treatment arms.
Common reasons for needing to be delivered at this early gestational age include but are not limited to: preterm labor not responding to tocolytic medications, incompetent cervix with cervical dilation and no contractions, clinical chorioamnionitis requiring delivery for maternal/fetal benefit, severe preeclampsia, severe growth restriction with a non-reassuring fetal heart rate tracing.
The first arm will include active milking of the umbilical cord toward the neonate's umbilicus prior to cord clamping at delivery while the second arm will not include this intervention and will have their respective cord immediately clamped in the usual fashion post delivery (control).
Study Type
Interventional
Enrollment (Actual)
113
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
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Virginia
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Norfolk, Virginia, United States, 23507
- Eastern Virginia Medical School
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Singleton pregnancy
- Delivery anticipated between 24 and 28+6 weeks gestation
- There is enough time from admission to anticipated delivery to properly obtain consent from the patient
Exclusion Criteria:
- Multifetal gestation
- Antenatally diagnosed major congenital anomaly
- Known Rh sensitized pregnancy
- Hydrops fetalis (any etiology)
- Known positive maternal Parvovirus titers
- Elevated peak systolic velocity of the fetal Middle Cerebral Artery (MCA)
- Clinical suspicion of placental abruption at delivery due to excessive maternal bleeding or uterine hypertonicity
- Maternal age under 18
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Control group, the cord was not milked
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Experimental: Umbilical Cord Milking
Approximately 10 cm of umbilical cord was milked toward the baby immediately following delivery
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Approximately 10 cm of umbilical cord was milked toward the baby immediately following delivery.
(The blood remaining in the umbilical cord after delivery is squeezed in the direction from the placenta (remaining inside the uterus) toward the newborn baby.)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Red blood cell transfusion
Time Frame: 28 days
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need for packed red blood cell transfusion in the first 28 days of neonatal life
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28 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Volume of blood transfusion
Time Frame: 28 days
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total volume of packed RBC's transfused in first 28 days of neonatal life
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28 days
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Intraventricular Hemorrhage
Time Frame: 28 days
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diagnosis of IVH in first 28 days of neonatal life
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28 days
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Days until transfusion
Time Frame: 28 days
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number of days until first RBC transfusion in first 28 days of life
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28 days
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Respiratory Distress Syndrome
Time Frame: 28 days
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diagnosis of RDS in first 28 days of neonatal life
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28 days
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Retinopathy of Prematurity
Time Frame: 28 days
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diagnosis of ROP in first 28 days of neonatal life
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28 days
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Chronic Lung Disease
Time Frame: 28 days
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diagnosis of CLD in first 28 days of neonatal life
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28 days
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Sepsis
Time Frame: 28 days
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diagnosis of sepsis in first 28 days of neonatal life
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28 days
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Necrotizing Enterocolitis
Time Frame: 28 days
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diagnosis of nec in first 28 days of neonatal life
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28 days
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Apgar scores
Time Frame: 10 minutes
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1, 5, and 10 minute Apgars scores
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10 minutes
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cord PH
Time Frame: 1 hour
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umbilical cord pH immediately after delivery
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1 hour
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Neonatal resuscitation
Time Frame: 1 hour
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Neonatal Resuscitation measures immediately after birth, including intubation, surfactant administration, stimulation, compressions, epinephrine
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1 hour
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Initial Hemoglobin/Hematocrit
Time Frame: 1 day
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Initial neonatal H/H
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1 day
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Initial blood pressure
Time Frame: 1 day
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Initial neonatal blood pressure
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1 day
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Neonatal jaundice
Time Frame: 28 days
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Need for bili lights to treat neonatal jaundice, maximum total bilirubin, number of days of bili lights
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28 days
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Neonatal death
Time Frame: 28 days
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Incidence of neonatal death in the first 28 days of life, age of neonate at death
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28 days
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Length of admission
Time Frame: 28 days
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Length of neonatal admission (up to 28 days)
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28 days
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Length of intubation
Time Frame: 28 days
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Length of need for neonatal intubation in first 28 days of life
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28 days
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Periventricular Leukomalacia
Time Frame: 28 days
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diagnosis of PVL in first 28 days of neonatal life
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28 days
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Hyperkalemia
Time Frame: 28 days
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diagnosis of Hyperkalemia in first 28 days of neonatal life
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28 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Margarita deVeciana, MD, Eastern Virginia Medical School
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
September 1, 2009
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
December 16, 2011
First Submitted That Met QC Criteria
January 30, 2012
First Posted (Estimate)
February 1, 2012
Study Record Updates
Last Update Posted (Estimate)
February 1, 2012
Last Update Submitted That Met QC Criteria
January 30, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EasternVMC
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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