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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anemia, Iron-Deficiency

Intervention / Treatment
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* Procedure: Umbilical cord milking


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Umbilical cord milking<br>The cord will be cut at 25 cm from the umbilical stump within 30 seconds after the infant is taken out from the uterus and its blood will be milked to the infant gently and thoroughly in 30 seconds during resuscitation on the radiant warmer, and then the cord will be cut at 2 to 3 cm from the umbilical stump. | Procedure: Umbilical cord milking<br>* As same as that in arm descriptions.<br>|
| No Intervention: Routine clinical treatment and care<br>The cord will be dealt with routine clinical method, which means it will be cut twice within 1minute after the infant is taken out from the uterus, the first cut is on the operating table, while the second cut is on the radiant warmer. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At birth (baseline), 6 and 12 months after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | At birth (baseline), 1, 6, 12 and 18 months after birth | 
| Infant's language development | The infant's development status of language will be assessed by the Language Developmental Survey (LDS). | 18 months old | 
| Infant's mental/behavioral development | The infant's mental/behavioral development will be assessed by the Child Behavior Checklist (CBCL). | 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. | 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. | 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. | Up to 18 months old | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Iron-Deficiency, Cesarean Section, Umbilical Cord Milking, Randomized Controlled Trial