Clinical Trial: Effect of Umbilical Cord Milking on Iron Related Health Outcomes for Cesarean-Delivered Infants

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effect of Umbilical Cord Milking on Iron Related Health Outcomes for Cesarean-Delivered Infants: A Randomized Controlled Trial

Brief Summary: This study aims to determine whether umbilical cord milking can improve iron related health outcomes for cesarean-delivered infants. Half of participants will receive umbilical cord milking, while the other half will receive routine clinical treatment and care.

Detailed Summary:

In recent years, several professional organizations have recommended delayed cord clamping to improve placental transfusion for newborns born vaginally based on a series of randomized controlled studies. However, no similar recommendations are available for cesarean-delivered infants. Investigators found that cesarean-delivered infants were more vulnerable to iron deficiency and anemia compared with those born vaginally, suggesting that it is urgently needed to find a similar anemia prevention strategy for infants born by cesarean sections.

In this study, investigators aim to test whether umbilical cord milking (UCM), a potentially promising strategy for cesarean delivery, can improve iron related health outcomes for cesarean-delivered infants. A total of 450 term pregnant women who are planning to give births by cesarean sections will be enrolled from two hospitals in Hunan province and randomly assigned to either UCM group or control group. Infants will be followed up at 1, 6, 12, 18 months for the evaluation of the impact of UCM on iron deficiency, anemia, as well as growth and the developmental status of language and mental/behavioral outcomes.


Sponsor: Peking University

Current Primary Outcome: Change in infant's serum ferritin (μg/L) [ Time Frame: At birth (baseline), 6 and 12 months after birth ]

At birth (baseline)-2 ml umbilical cord blood, 6 and 12 months old-2 ml infant's venous blood for each measure.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in infant's erythrocyte counts (10^12/L) [ Time Frame: At birth (baseline), 1, 6 and 12 months after birth ]
    At birth (baseline)-1 ml umbilical cord blood, 1 month old-20 μL infant's peripheral blood of finger, 6 and 12 months old-1 ml infants' venous blood for each measure.
  • Change in infant's hemoglobin concentration (g/L) [ Time Frame: At birth (baseline), 1, 6 and 12 months after birth ]
    A participant's erythrocyte counts and hemoglobin concentration are detected using the same blood sample.
  • Change in infant's hematocrit (%) [ Time Frame: At birth (baseline), 1, 6 and 12 months after birth ]
    A participant's erythrocyte counts, hemoglobin concentration and hematocrit are detected using the same blood sample.
  • Change in infant's weight (kg) [ Time Frame: At birth (baseline), 1, 6, 12 and 18 months after birth ]
    Every infant's weight will be measured twice each time, but if the difference between the two measurement results is more than 0.1 kg, it will be measured for the third time.
  • Change in infant's height (cm) [ Time Frame: At birth (baseline), 1, 6, 12 and 18 months after birth ]
    Every infant's height will be measured twice each time, but if the difference between the two measurement results is more than 0.5 cm, it will be measured for the third time.
  • Infant's language development [ Time Frame: 18 months old ]
    The infant's development status of language will be assessed by the Language Developmental Survey (LDS).
  • Infant's mental/behavioral development [ Time Frame: 18 months old ]
    The infant's mental/behavioral development will be assessed by the Child Behavior Checklist (CBCL).
  • Change in infant's transcutaneous bilirubin concentration (mg/dL) [ Time Frame: 1 (baseline), 2, 3, 4 and 5 days after birth ]
    An infant's transcutaneous bilirubin concentration will be detected for five days after birth with time recorded. To ensure accuracy, each time it will be repeatedly detected for three times.
  • Number of infants with neonatal jaundice in the experimental group and the control group [ Time Frame: Up to 18 months old ]
    At each follow-up visit (1, 6, 12 and 18 months after birth), parents will be asked whether their children suffer from jaundice up to then. If so, the doctor will ask them about the onset time, possible causes, treatment and prognosis of the disease.
  • Number of infants with polycythemia in the experimental group and the control group [ Time Frame: Up to 18 months old ]
    At each follow-up visit (1, 6, 12 and 18 months after birth), parents will be asked whether their children suffer from polycythemia up to then.


Original Secondary Outcome: Same as current

Information By: Peking University

Dates:
Date Received: August 23, 2016
Date Started: July 2016
Date Completion: December 2018
Last Updated: September 1, 2016
Last Verified: September 2016