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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
484
As same as that in arm descriptions.
Hunan Provincial Maternal and Child Health Care Hospital
Changsha, Hunan, China
Liuyang Maternal and Child Health Care Hospital
Guankou, Hunan, China
Change in infant's serum ferritin (μg/L)
At birth (baseline)-2 ml umbilical cord blood, 6 and 12 months old-2 ml infant's venous blood for each measure.
Time frame: At birth (baseline), 6 and 12 months after birth
Change in infant's erythrocyte counts (10^12/L)
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.
Time frame: At birth (baseline), 1, 6 and 12 months after birth
Change in infant's hemoglobin concentration (g/L)
A participant's erythrocyte counts and hemoglobin concentration are detected using the same blood sample.
Time frame: At birth (baseline), 1, 6 and 12 months after birth
Change in infant's hematocrit (%)
A participant's erythrocyte counts, hemoglobin concentration and hematocrit are detected using the same blood sample.
Time frame: At birth (baseline), 1, 6 and 12 months after birth
Change in infant's weight (kg)
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.
Time frame: At birth (baseline), 1, 6, 12 and 18 months after birth
Change in infant's height (cm)
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.
Time frame: At birth (baseline), 1, 6, 12 and 18 months after birth
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Infant's language development
The infant's development status of language will be assessed by the Language Developmental Survey (LDS).
Time frame: 18 months old
Infant's mental/behavioral development
The infant's mental/behavioral development will be assessed by the Child Behavior Checklist (CBCL).
Time frame: 18 months old
Change in infant's transcutaneous bilirubin concentration (mg/dL)
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.
Time frame: 1 (baseline), 2, 3, 4 and 5 days after birth
Number of infants with neonatal jaundice in the experimental group and the control group
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.
Time frame: Up to 18 months old
Number of infants with polycythemia in the experimental group and the control group
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.
Time frame: Up to 18 months old