Anemia, Iron-Deficiency
Conditions
Keywords
Anemia, Iron-Deficiency, Cesarean Section, Umbilical Cord Milking, 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 description
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.
Interventions
PROCEDUREUmbilical cord milking
As same as that in arm descriptions.
Sponsors
National Natural Science Foundation of China
Hunan Provincial Maternal and Child Health Care Hospital
Liuyang Maternal and Child Health Care Hospital
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Singleton pregnancy * Full-term pregnancy (no less than 37 gestational weeks) * Cesarean section before the labor starts or cesarean section after the labor starts but with cervix less than 3 cm * Plan to take vaccines and receive routine child health care in the hospital where she gives birth
Exclusion criteria
* Maternal hypertensive disorder * Gestational diabetes with macrosomia * Gestational diabetes with polyhydramnios * Maternal severe anemia with hemoglobin less than 70 g/L * Maternal coagulation disorders * Fetal growth restriction * Major congenital anomalies * Hemolytic disease of the newborn or hydrops fetalis * Short umbilical cord length (\< 30 cm) * Severe cord or placenta abnormalities such as cord prolapse, true knots, placental abruption and placenta previa * Other conditions that are not suitable for the study judged by the doctors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in infant's serum ferritin (μg/L) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in infant's hemoglobin concentration (g/L) | 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 (%) | 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) | 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) | 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. |
| Change in infant's erythrocyte counts (10^12/L) | 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. |
| Infant's mental/behavioral development | 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) | 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 | 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 | 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. |
| Infant's language development | 18 months old | The infant's development status of language will be assessed by the Language Developmental Survey (LDS). |
Countries
China
Outcome results
None listed