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The Study on Umbilical Cord Milking to Prevent and Decrease the Severity of Anemia in preterms--a Multi-center Randomized Controlled Trial (NCT03023917)

Shanghai First Maternity and Infant Hospital
Yangpu District Central Hospital Affiliated to Tongji University
The overall objective of the present study is to examine the effects of umbilical cord milking at birth in preterm infants to prevent and decrease anemia using a multi-center prospective randomized controlled trial comparing immediate cord clamping (standard at present) with umbilical cord milking.
  • Procedure: umbilical cord milking
    Infants were placed at or below level of the placenta and about 25cm of the umbilical cord was vigorously milked towards the umbilicus two to three times before clamping the cord. The milking speed was about 25cm/2 seconds
    • Procedure: umbilical cord clamping immediately
      umbilical cord was cut immediately after birth
      Ages eligible for Study
      all
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      Inclusion Criteria:
      • Women in labour or with a plan for delivery at a gestational age less than 34 weeks gestation.
      • Singleton pregnancy
      • informed consent was obtained from the parent
      Exclusion Criteria:
      • Multiple gestation
      • Diagnosis of any of the following in the current pregnancy: hemorrhage requiring clinic/hospital admission, placental abnormalities, fetal anomalies, Down's syndrome of the fetus,anemia
      • Diagnosis of pre-eclampsia or eclampsia in current or previous pregnancies
      • Diagnosis at any time for the mother of any of the following: serious Diabetes, serious hypertension, chronic renal disease
      • Infant with major congenital malformation
      • Infant with blood disease
      • Unwilling to return for follow-up study visits at the hospital
      Anemia is a significant problem for pre-term infants and a major risk factor for preterm babies mortality and morbidity in neonatal intensive care unit(NICU). the majority of pre-term babies will require one or more blood transfusions during in NICU. Blood transfusion is a safe procedure but like all therapeutic interventions has risks associated with it and effort is made to reduce the number of transfusions that infants require during their stay on the neonatal unit.

      Delayed cord clamping has a beneficial effect on prevention of anemia in later infancy because of increased iron stores at birth. However there are controversies in incorporating delayed cord clamping practice in the management of third stage of labour globally. Concerning about the need for urgent resuscitation and temperature management, attendants encouraged to clamp the umbilical cord immediately so that post-natal resuscitation and care can start as soon as possible.However,umbilical cord milking allows for swift intervention and resuscitation and attention to thermal care and should take less than 10 seconds to complete.

      The specific aim of this study is to investigate the effects of umbilical cord milking on preventing and decreasing anemia in very pre-term infants.

      Primary:

      To study the effect of umbilical cord milking on hemoglobin (Hb), Hematocrit (Hct)and ferritin at birth, at seventh day and three months of age.

      Secondary:

      To study the effect of umbilical cord milking on short term clinical profile of neonates like jaundice, polycythemia etc.

      To evaluate the number of blood transfusions until 3 months corrected gestational age (CGA), To assess preterm infant complications such as lung function as assessed by oxygen dependency at 36 weeks corrected gestational age (CGA), and cardiovascular function as assessed by the need for volume expansion, inotropes, or clinically suspected patent ductus arteriosus(PDA )requiring intervention prior to discharge home,incidence of intraventricular hemorrhage and late-onset sepsis,etc.
      Status:
      not yet recruiting
      Type:
      Interventional
      Phase:
      Ⅰ, Ⅱ
      Start:
      31 May, 2017
      Updated:
      12 January, 2017
      Participants:
      300
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