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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01523769
Other study ID # EasternVMC
Secondary ID
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


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
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