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NCT Number: NCT02892461

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

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.

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Key information

Conditions

Anemia, Iron-Deficiency Anemia Anemia, Hypochromic Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hunan Provincial Maternal and Child Health Care Hospital, Changsha, Hunan, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Umbilical Cord Milking

Procedure

As same as that in arm descriptions.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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).

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Peking University

Other

Collaborators

  • Hunan Provincial Maternal and Child Health Care Hospital
  • Liuyang Maternal and Child Health Care Hospital
  • National Natural Science Foundation of China

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Sep 8, 2016
Registry last updated
Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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