Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants

Not Applicable

Completed

• Conditions: Prematurity
• Interventions: Procedure: Umbilical Cord Milking

• Registration Number: NCT01523769
• Lead Sponsor: Eastern Virginia Medical School

Brief Summary

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.

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 Timeline

• Study Start: 2009-09
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Study First Submitted: 2011-12-16
• Status Verified: 2012-01
• Study First Submitted QC: 2012-01-30
• Last Update Submitted: 2012-01-30
• Study First Posted: 2012-02-01
• Last Update Posted: 2012-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 113

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Umbilical Cord Milking	Umbilical Cord Milking	Approximately 10 cm of umbilical cord was milked toward the baby immediately following delivery

Primary Outcome Measures

Name	Time	Method
Red blood cell transfusion	28 days	need for packed red blood cell transfusion in the first 28 days of neonatal life

Secondary Outcome Measures

Name	Time	Method
Volume of blood transfusion	28 days	total volume of packed RBC's transfused in first 28 days of neonatal life
Intraventricular Hemorrhage	28 days	diagnosis of IVH in first 28 days of neonatal life
Days until transfusion	28 days	number of days until first RBC transfusion in first 28 days of life
Respiratory Distress Syndrome	28 days	diagnosis of RDS in first 28 days of neonatal life
Retinopathy of Prematurity	28 days	diagnosis of ROP in first 28 days of neonatal life
Chronic Lung Disease	28 days	diagnosis of CLD in first 28 days of neonatal life
Sepsis	28 days	diagnosis of sepsis in first 28 days of neonatal life
Necrotizing Enterocolitis	28 days	diagnosis of nec in first 28 days of neonatal life
Apgar scores	10 minutes	1, 5, and 10 minute Apgars scores
cord PH	1 hour	umbilical cord pH immediately after delivery
Neonatal resuscitation	1 hour	Neonatal Resuscitation measures immediately after birth, including intubation, surfactant administration, stimulation, compressions, epinephrine
Initial Hemoglobin/Hematocrit	1 day	Initial neonatal H/H
Initial blood pressure	1 day	Initial neonatal blood pressure
Neonatal jaundice	28 days	Need for bili lights to treat neonatal jaundice, maximum total bilirubin, number of days of bili lights
Neonatal death	28 days	Incidence of neonatal death in the first 28 days of life, age of neonate at death
Length of admission	28 days	Length of neonatal admission (up to 28 days)
Length of intubation	28 days	Length of need for neonatal intubation in first 28 days of life
Periventricular Leukomalacia	28 days	diagnosis of PVL in first 28 days of neonatal life
Hyperkalemia	28 days	diagnosis of Hyperkalemia in first 28 days of neonatal life

Trial Locations

Locations (1)

Eastern Virginia Medical School; 🇺🇸 Norfolk, Virginia, United States