Association Between Blood Volume, the Interval From Delivery to Cord Clamping, and Number of Umbilical Cord Milking
Condition: Pregnancy Related; Umbilical Cord Issue; Placental Transfusion
Study type: Interventional

Summary: 
      Delayed umbilical cord clamping (DCC), usually 1-3 minutes, is reported to be beneficial for
      term and preterm infants. Nevertheless, there are reasons that urge us to reevaluate the
      effect of DCC. First, most prior studies were conducted on American and European women. The
      benefits of DCC in the infants born to Asian women is not clear. Second, neonates born to
      Asian mothers usually have lower birth weights and placental weights compared to the neonates
      and placentas of American and European women. The optimal duration of DCC in Asian women
      remains undetermined. The objective of this study is to determine the association between the
      blood volume collected and the interval from delivery to cord clamping and number of
      umbilical cord milking in women with normal term pregnancies with vaginal delivery or
      elective cesarean delivery (CS). Results form this study will help us determine the optimal
      duration of DCC or numbers of cord milking in our population in the following studies.
    

Detailed description: 
      Delayed umbilical cord clamping (DCC), usually 1-3 minutes, is reported to be beneficial for
      term and preterm infants. In term infants, DCC increases hemoglobin levels at birth and
      improves iron stores in the first several months of life, which may have a favorable effect
      on development outcomes. In preterm infants, the benefits of DCC include improved
      transitional circulation, better establishment of red blood cell volume, decreased need for
      blood transfusion, and lower incidence of necrotizing enterocolitis and intraventricular
      hemorrhage. DCC was not associated with increased risk of postpartum hemorrhage or increased
      blood loss at delivery, nor was it associated with the need for blood transfusion. Three is a
      small increase in the incidence of jaundice that requires phototherapy in infants undergoing
      DCC. Given the benefits of most newborns, a number of professional organizations recommends
      DCC in term and preterm infants, when feasible.

      There are reasons that urge us to reevaluate the effect of DCC in our population. First, most
      prior studies were conducted on American and European women. The benefits of DCC in the
      infants born to Asian women is not clear. Second, neonates born to Asian mothers usually have
      lower birth weights and placental weights compared to the neonates and placentas of American
      and European women. The optimal duration of DCC in Asian women remains undetermined. With the
      aforementioned reasons, the investigators will conduct a study to clarify the effects of DCC
      and umbilical cord milking on maternal and neonatal outcomes in Taiwanese women. Our
      objective is to determine the association between the blood volume collected and the interval
      from delivery to cord clamping and number of umbilical cord milking in women with normal term
      pregnancies with vaginal delivery or elective cesarean delivery (CS);.
    

Intervention name(s): cord blood spontaneous drainage; Umbilical cord miking
Intervention type(s): Procedure; Procedure
Intervention description(s): In women allocated to groups of cord blood spontaneous drainage, two clamps will placed at 4 finger breadths from the infant's abdomen and cut between two clamps after delivery of the baby. The clamp on the placental site will be removed and the drainage time and amount of cord blood to a measuring glass will be recored.; In women allocated to groups of cord milking group, two clamps will placed at 4 finger breadths from the newborn's abdomen and cut between two clamps immediately after delivery of the baby. The clamp on the placental site will be removed, then the umbilical cord will be squeezed several times, 5 seconds between each squeezing, to collect cord blood in a measuring glass. The number of cord milking and the volume of blood collected will be recorded.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The investigators will recruit 80 women normal term pregnancy; 40 with vaginal delivery and 40 with elective CS for previous CS or fetal malpresentation.
Participants will be randomized into 4 groups: group 1, vaginal delivery with cord blood spontaneous drainage; group 2, vaginal delivery with cord milking; group 3, CS with cord blood spontaneous drainage; group 4, CS with cord milking. In women allocated to groups of cord blood spontaneous drainage, two clamps will placed at 4 finger breadths from the infant's abdomen and cut between two clamps. The newborns will be taken care by the nurse after delivery. The clamp on the placenta site will be removed and record the drainage time and amount of cord blood to a measuring glass. In women allocated to groups of cord milking group, the umbilical cord will be squeezed several times, 5 seconds between each squeezing, to collect cord blood after delivery. The number of cord milking and the volume of blood collected will be recorded.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Delayed umbilical cord clamping; umbilical cord milking