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

NCT ID: NCT01523769

Last Updated: 2012-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-11-30

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).

Conditions

Prematurity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Control group, the cord was not milked

Group Type: NO_INTERVENTION

No interventions assigned to this group

Umbilical Cord Milking

Approximately 10 cm of umbilical cord was milked toward the baby immediately following delivery

Group Type: EXPERIMENTAL

Umbilical Cord Milking

Intervention Type: PROCEDURE

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.)

Interventions

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.)

Intervention Type: PROCEDURE

Other Intervention Names

Umbilical Cord Milking, autotransfusion

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eastern Virginia Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margarita deVeciana, MD

Role: PRINCIPAL_INVESTIGATOR

Eastern Virginia Medical School

Locations

Eastern Virginia Medical School

Norfolk, Virginia, United States

Countries

United States

Other Identifiers

EasternVMC

Identifier Type: -

Identifier Source: org_study_id