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Completed

NCT Number: NCT01523769

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Umbilical Cord Milking

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.)

Other names: Umbilical Cord Milking, autotransfusion

Primary outcomes

  1. Red blood cell transfusion

    Time frame: 28 days

    need for packed red blood cell transfusion in the first 28 days of neonatal life

Secondary outcomes

  1. Volume of blood transfusion

    Time frame: 28 days

    total volume of packed RBC's transfused in first 28 days of neonatal life

  2. Intraventricular Hemorrhage

    Time frame: 28 days

    diagnosis of IVH in first 28 days of neonatal life

  3. Days until transfusion

    Time frame: 28 days

    number of days until first RBC transfusion in first 28 days of life

  4. Respiratory Distress Syndrome

    Time frame: 28 days

    diagnosis of RDS in first 28 days of neonatal life

  5. Retinopathy of Prematurity

    Time frame: 28 days

    diagnosis of ROP in first 28 days of neonatal life

  6. Chronic Lung Disease

    Time frame: 28 days

    diagnosis of CLD in first 28 days of neonatal life

  7. Sepsis

    Time frame: 28 days

    diagnosis of sepsis in first 28 days of neonatal life

  8. Necrotizing Enterocolitis

    Time frame: 28 days

    diagnosis of nec in first 28 days of neonatal life

  9. Apgar scores

    Time frame: 10 minutes

    1, 5, and 10 minute Apgars scores

  10. cord PH

    Time frame: 1 hour

    umbilical cord pH immediately after delivery

  11. Neonatal resuscitation

    Time frame: 1 hour

    Neonatal Resuscitation measures immediately after birth, including intubation, surfactant administration, stimulation, compressions, epinephrine

  12. Initial Hemoglobin/Hematocrit

    Time frame: 1 day

    Initial neonatal H/H

  13. Initial blood pressure

    Time frame: 1 day

    Initial neonatal blood pressure

  14. Neonatal jaundice

    Time frame: 28 days

    Need for bili lights to treat neonatal jaundice, maximum total bilirubin, number of days of bili lights

  15. Neonatal death

    Time frame: 28 days

    Incidence of neonatal death in the first 28 days of life, age of neonate at death

  16. Length of admission

    Time frame: 28 days

    Length of neonatal admission (up to 28 days)

  17. Length of intubation

    Time frame: 28 days

    Length of need for neonatal intubation in first 28 days of life

  18. Periventricular Leukomalacia

    Time frame: 28 days

    diagnosis of PVL in first 28 days of neonatal life

  19. Hyperkalemia

    Time frame: 28 days

    diagnosis of Hyperkalemia in first 28 days of neonatal life

Sponsors and collaborators

Lead sponsor

Eastern Virginia Medical School

Other

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 1, 2012
Registry last updated
Feb 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.