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

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ClinicalTrials.gov Identifier: NCT02892461
Recruitment Status : Unknown
Verified September 2016 by Jianmeng Liu, Peking University.
Recruitment status was:  Recruiting
First Posted : September 8, 2016
Last Update Posted : September 8, 2016
Sponsor:
Collaborators:
National Natural Science Foundation of China
Hunan Provincial Maternal and Child Health Care Hospital
Liuyang Maternal and Child Health Care Hospital
Information provided by (Responsible Party):
Jianmeng Liu, Peking University

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.

Condition or disease Intervention/treatment Phase
Anemia, Iron-Deficiency Procedure: Umbilical cord milking Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Umbilical Cord Milking on Iron Related Health Outcomes for Cesarean-Delivered Infants: A Randomized Controlled Trial
Study Start Date : July 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: Umbilical cord milking
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
As same as that in arm descriptions.

No Intervention: Routine clinical treatment and care
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892461


Contacts
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Contact: Jianmeng Liu, PhD 8613911460833 liujm@pku.edu.cn
Contact: Hongtian Li, PhD 8618600003037 hongtian821207@126.com

Locations
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China, Hunan
Hunan Provincial Maternal and Child Health Care Hospital Recruiting
Changsha, Hunan, China, 410008
Contact: Qiyun Du, MD    011-86-731-84332141    dqyun@163.com   
Contact: Donghua Xie, MD    8613875894705      
Liuyang Maternal and Child Health Care Hospital Recruiting
Liuyang, Hunan, China, 410399
Contact: Shujin Zhou, B.S.Med    011-86-731-83661363    zhoushujin918@126.com   
Contact: Huihuang Zhou, B.S.Med    8613467545616      
Sponsors and Collaborators
Peking University
National Natural Science Foundation of China
Hunan Provincial Maternal and Child Health Care Hospital
Liuyang Maternal and Child Health Care Hospital
Investigators
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Study Chair: Jianmeng Liu, PhD Peking University
Principal Investigator: Hongtian Li, PhD Peking University
Principal Investigator: Yubo Zhou, PhD Peking University
Principal Investigator: Qiyun Du, MD Hunan Provincial Maternal and Child Health Care Hospital
Principal Investigator: Shujin Zhou, B.S.Med Liuyang Maternal and Child Health Care Hospital

Publications:

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Responsible Party: Jianmeng Liu, Professor in Epidemiology and Biostatistics; Director of Institute of Reproductive and Child Health, Peking University; Director of Office for National Maternal and Child Health Statistics of China, Peking University
ClinicalTrials.gov Identifier: NCT02892461     History of Changes
Other Study ID Numbers: 81571517
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jianmeng Liu, Peking University:
Anemia, Iron-Deficiency
Cesarean Section
Umbilical Cord Milking
Randomized Controlled Trial
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs