Clinical trial NCT01523769: Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Keywords: prematurity
umbilical cord milking
delayed cord clamping
neonatal transfusion
Lead sponsor: Eastern Virginia Medical School
Sponsor class: OTHER
First posted: 2012-02-01
Enrollment: 113
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Red blood cell transfusion
timeFrame: 28 days
Secondary outcomes:
measure: Volume of blood transfusion
timeFrame: 28 days
measure: Intraventricular Hemorrhage
timeFrame: 28 days
measure: Days until transfusion
timeFrame: 28 days
measure: Respiratory Distress Syndrome
timeFrame: 28 days
measure: Retinopathy of Prematurity
timeFrame: 28 days
measure: Chronic Lung Disease
timeFrame: 28 days
measure: Sepsis
timeFrame: 28 days
measure: Necrotizing Enterocolitis
timeFrame: 28 days
measure: Apgar scores
timeFrame: 10 minutes
measure: cord PH
timeFrame: 1 hour
measure: Neonatal resuscitation
timeFrame: 1 hour
measure: Initial Hemoglobin/Hematocrit
timeFrame: 1 day
measure: Initial blood pressure
timeFrame: 1 day
measure: Neonatal jaundice
timeFrame: 28 days
measure: Neonatal death
timeFrame: 28 days
measure: Length of admission
timeFrame: 28 days
measure: Length of intubation
timeFrame: 28 days
measure: Periventricular Leukomalacia
timeFrame: 28 days
measure: Hyperkalemia
timeFrame: 28 days
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
Study officials:
affiliation: Eastern Virginia Medical School
name: Margarita deVeciana, MD
role: PRINCIPAL_INVESTIGATOR
References: