An interventional study of Umbilical Cord Milking in Prematurity, sponsored by Eastern Virginia Medical School. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-02-01.
Sponsored by Eastern Virginia Medical School · Not applicable, Interventional, and Treatment
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.
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).
2,553 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 113 is above the median of 84 across 1,688 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Eastern Virginia Medical School is the lead sponsor of 56 studies on the registry; 8 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Control group, the cord was not milked
Approximately 10 cm of umbilical cord was milked toward the baby immediately following delivery
Procedure: Umbilical Cord Milking
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.)
Also known as: Umbilical Cord Milking, autotransfusion
Red blood cell transfusion
need for packed red blood cell transfusion in the first 28 days of neonatal life
Time frame: 28 days
Volume of blood transfusion
total volume of packed RBC's transfused in first 28 days of neonatal life
Time frame: 28 days
Intraventricular Hemorrhage
diagnosis of IVH in first 28 days of neonatal life
Time frame: 28 days
Days until transfusion
number of days until first RBC transfusion in first 28 days of life
Time frame: 28 days
Respiratory Distress Syndrome
diagnosis of RDS in first 28 days of neonatal life
Time frame: 28 days
Retinopathy of Prematurity
diagnosis of ROP in first 28 days of neonatal life
Time frame: 28 days
Chronic Lung Disease
diagnosis of CLD in first 28 days of neonatal life
Time frame: 28 days
Sepsis
diagnosis of sepsis in first 28 days of neonatal life
Time frame: 28 days
Necrotizing Enterocolitis
diagnosis of nec in first 28 days of neonatal life
Time frame: 28 days
Apgar scores
1, 5, and 10 minute Apgars scores
Time frame: 10 minutes
cord PH
umbilical cord pH immediately after delivery
Time frame: 1 hour
Neonatal resuscitation
Neonatal Resuscitation measures immediately after birth, including intubation, surfactant administration, stimulation, compressions, epinephrine
Time frame: 1 hour
Initial Hemoglobin/Hematocrit
Initial neonatal H/H
Time frame: 1 day
Initial blood pressure
Initial neonatal blood pressure
Time frame: 1 day
Neonatal jaundice
Need for bili lights to treat neonatal jaundice, maximum total bilirubin, number of days of bili lights
Time frame: 28 days
Neonatal death
Incidence of neonatal death in the first 28 days of life, age of neonate at death
Time frame: 28 days
Length of admission
Length of neonatal admission (up to 28 days)
Time frame: 28 days
Length of intubation
Length of need for neonatal intubation in first 28 days of life
Time frame: 28 days
Periventricular Leukomalacia
diagnosis of PVL in first 28 days of neonatal life
Time frame: 28 days
Hyperkalemia
diagnosis of Hyperkalemia in first 28 days of neonatal life
Time frame: 28 days
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Eastern Virginia Medical School