Milking the Umbilical Cord at Term Cesarean Birth
Condition: Anemia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this pilot study is to determine if umbilical cord milking at the time of
      scheduled cesarean section effects the hemoglobin and hematocrit levels of full-term infants
      as determined by hemoglobin and hematocrit levels at 36-48 hours of life. This study will
      help to establish the feasibility of umbilical cord milking as an alternative to delayed
      clamping at the time of planned cesarean section.
    

Detailed description: 
      New evidence suggests the practice of immediate clamping and cutting of the umbilical cord at
      birth may contribute to anemia in infancy. Immediate clamping can deprive a full term infant
      of 60 to 100 ml of whole blood representing 30 to 50 mg/kg of iron. The "low tech-low cost"
      intervention of delayed cord clamping can reduce anemia in infancy by enhancing
      placental-infant transfusion at birth. The risk of maternal bleeding makes a delay in cord
      clamping at the time of cesarean section challenging. In the United States (US), immediate
      clamping and cutting of the umbilical cord is the usual practice at the time of cesarean
      section. Milking of the umbilical cord may offer an alternative to delayed cord clamping for
      the prevention of anemia in infancy when time and speed are critical factors at the time of
      cesarean section. Although some obstetrical and pediatric providers fear adverse outcomes
      from delayed cord clamping or umbilical cord milking such as polycythemia or jaundice, the
      most recent clinical trials fail to support these fears.

      In spite of iron supplementation and iron fortified formula and food, iron deficiency in
      infants and toddlers remains a significant public health problem in the US. Poor iron stores
      in the first year of life can lead to iron deficiency which has the potential to cause harm
      to the developing brain.

      The number of births by cesarean section is on the rise in this country. According to the
      latest US birth data reported by the National Center for Health Statistics, the cesarean
      section rate is now above 32%, over a 50% increase since 1996. Immediate cord clamping is
      routine practice at the time of cesarean section in the US. Consequently over 1.4 million
      babies annually will have their umbilical cords cut immediately at the time of birth. This
      routine practice interferes in placental transfusion and results in less blood volume and red
      blood cells and increases anemia at birth and lowers total body iron stores in the newborn at
      six months. The potential effect of immediate cord clamping at cesarean section is enormous
      on the public health of infants in this country. However the association between cord
      clamping time and infant well-being is not generally recognized by clinicians.

      Delaying the clamping and cutting of the cord for just two minutes is known to offer benefit
      and can improve the iron stores of term newborns extending into at least the first six months
      of life. Although there is benefit for the baby, a two minute delay is not feasible for the
      mother at time of cesarean section. However, milking of the umbilical cord at the time of
      cesarean section may be a viable alternative to delayed cord clamping and may prevent anemia
      and infant iron deficiency. Most of the available literature on umbilical cord milking was
      written over 50 years ago. Even so, these studies support the technique as safe for term
      infants resulting in higher neonatal hemoglobin and hematocrit levels. One recent study found
      cord milking was beneficial and did not cause harm in very low birth weight preterm infants.

      This study will help to establish the feasibility of using umbilical cord milking as an
      alternative to delayed cord clamping at the time of cesarean section. Umbilical cord milking
      will be examined as a selective intervention to accelerate placental transfusion when delayed
      clamping is not ideal. It has the potential to prevent anemia and iron deficiency in infancy
      in full-term infants born by cesarean section.
    

Intervention name(s): Umbilical Cord Milking
Intervention type(s): Other
Intervention description(s): At birth, the infant will be held below the level of the placenta and umbilical cord will be milked 5 times after birth and before clamping the cord.
Other intervention name(s): Umbilical Cord Stripping
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: umbilical cord milking; umbilical cord stripping; umbilical cord clamping; placental transfusion; placental residual blood volume