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

Prematurity Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523769
• Other study ID #: EasternVMC
• Status: Completed
• Phase: N/A
• First received: December 16, 2011
• Last updated: January 30, 2012
• Start date: September 2009
• Est. completion date: November 2011

Study information

• Verified date: January 2012
• Source: Eastern Virginia Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Prematurity

Intervention

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.)

Locations

Country	Name	City	State
United States	Eastern Virginia Medical School	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Virginia Medical School

Country where clinical trial is conducted

United States, 

Outcome

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