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

Primary Purpose

Anemia, Iron-Deficiency

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Umbilical cord milking
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anemia, Iron-Deficiency focused on measuring Anemia, Iron-Deficiency, Cesarean Section, Umbilical Cord Milking, Randomized Controlled Trial

Eligibility Criteria

20 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hunan Provincial Maternal and Child Health Care Hospital
  • Liuyang Maternal and Child Health Care Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Umbilical cord milking

Routine clinical treatment and care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Change in infant's hemoglobin concentration (g/L)
A participant's erythrocyte counts and hemoglobin concentration are detected using the same blood sample.
Change in infant's hematocrit (%)
A participant's erythrocyte counts, hemoglobin concentration and hematocrit are detected using the same blood sample.
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.
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.
Infant's language development
The infant's development status of language will be assessed by the Language Developmental Survey (LDS).
Infant's mental/behavioral development
The infant's mental/behavioral development will be assessed by the Child Behavior Checklist (CBCL).
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.
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.
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.

Full Information

First Posted
August 23, 2016
Last Updated
March 15, 2020
Sponsor
Peking University
Collaborators
National Natural Science Foundation of China, Hunan Provincial Maternal and Child Health Care Hospital, Liuyang Maternal and Child Health Care Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02892461
Brief Title
Effect of Umbilical Cord Milking on Iron Related Health Outcomes for Cesarean-Delivered Infants
Official Title
Effect of Umbilical Cord Milking on Iron Related Health Outcomes for Cesarean-Delivered Infants: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
Collaborators
National Natural Science Foundation of China, Hunan Provincial Maternal and Child Health Care Hospital, Liuyang Maternal and Child Health Care Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Iron-Deficiency
Keywords
Anemia, Iron-Deficiency, Cesarean Section, Umbilical Cord Milking, Randomized Controlled Trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
484 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Umbilical cord milking
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine clinical treatment and care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Umbilical cord milking
Intervention Description
As same as that in arm descriptions.
Primary Outcome Measure Information:
Title
Change in infant's serum ferritin (μg/L)
Description
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
Secondary Outcome Measure Information:
Title
Change in infant's erythrocyte counts (10^12/L)
Description
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
Title
Change in infant's hemoglobin concentration (g/L)
Description
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
Title
Change in infant's hematocrit (%)
Description
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
Title
Change in infant's weight (kg)
Description
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
Title
Change in infant's height (cm)
Description
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
Title
Infant's language development
Description
The infant's development status of language will be assessed by the Language Developmental Survey (LDS).
Time Frame
18 months old
Title
Infant's mental/behavioral development
Description
The infant's mental/behavioral development will be assessed by the Child Behavior Checklist (CBCL).
Time Frame
18 months old
Title
Change in infant's transcutaneous bilirubin concentration (mg/dL)
Description
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
Title
Number of infants with neonatal jaundice in the experimental group and the control group
Description
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
Title
Number of infants with polycythemia in the experimental group and the control group
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianmeng Liu, PhD
Organizational Affiliation
Peking University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hongtian Li, PhD
Organizational Affiliation
Peking University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yubo Zhou, PhD
Organizational Affiliation
Peking University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qiyun Du, MD
Organizational Affiliation
Hunan Provincial Maternal and Child Health Care Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shujin Zhou, B.S.Med
Organizational Affiliation
Liuyang Maternal and Child Health Care Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunan Provincial Maternal and Child Health Care Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Liuyang Maternal and Child Health Care Hospital
City
Liuyang
State/Province
Hunan
ZIP/Postal Code
410399
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25733637
Citation
Li HT, Trasande L, Zhu LP, Ye RW, Zhou YB, Liu JM. Association of cesarean delivery with anemia in infants and children in 2 large longitudinal Chinese birth cohorts. Am J Clin Nutr. 2015 Mar;101(3):523-9. doi: 10.3945/ajcn.114.092585. Epub 2014 Dec 24.
Results Reference
background
PubMed Identifier
23843134
Citation
McDonald SJ, Middleton P, Dowswell T, Morris PS. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2013 Jul 11;2013(7):CD004074. doi: 10.1002/14651858.CD004074.pub3.
Results Reference
background
PubMed Identifier
17374818
Citation
Hutton EK, Hassan ES. Late vs early clamping of the umbilical cord in full-term neonates: systematic review and meta-analysis of controlled trials. JAMA. 2007 Mar 21;297(11):1241-52. doi: 10.1001/jama.297.11.1241.
Results Reference
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PubMed Identifier
20956259
Citation
Perlman JM, Wyllie J, Kattwinkel J, Atkins DL, Chameides L, Goldsmith JP, Guinsburg R, Hazinski MF, Morley C, Richmond S, Simon WM, Singhal N, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Part 11: Neonatal resuscitation: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2010 Oct 19;122(16 Suppl 2):S516-38. doi: 10.1161/CIRCULATIONAHA.110.971127. No abstract available.
Results Reference
background
PubMed Identifier
23168790
Citation
Committee on Obstetric Practice, American College of Obstetricians and Gynecologists. Committee Opinion No.543: Timing of umbilical cord clamping after birth. Obstet Gynecol. 2012 Dec;120(6):1522-6. doi: 10.1097/01.AOG.0000423817.47165.48.
Results Reference
background
PubMed Identifier
18137215
Citation
McCAUSLAND AM, HOLMES F, SCHUMANN WR. Management of cord and placental blood and its effect upon the newborn. Calif Med. 1949 Sep;71(3):190-6.
Results Reference
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PubMed Identifier
14923706
Citation
SIDDALL RS, CRISSEY RR, KNAPP WL. Effect on cesarean section babies of stripping or milking of the umbilical cords. Am J Obstet Gynecol. 1952 May;63(5):1059-64. doi: 10.1016/0002-9378(52)90546-2. No abstract available.
Results Reference
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PubMed Identifier
8616446
Citation
Daniel DG, Weerakkody AN. Neonatal prevention of iron deficiency. Blood can be transfused from cord clamped at placental end. BMJ. 1996 Apr 27;312(7038):1102-3. doi: 10.1136/bmj.312.7038.1102d. No abstract available.
Results Reference
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PubMed Identifier
23123382
Citation
Upadhyay A, Gothwal S, Parihar R, Garg A, Gupta A, Chawla D, Gulati IK. Effect of umbilical cord milking in term and near term infants: randomized control trial. Am J Obstet Gynecol. 2013 Feb;208(2):120.e1-6. doi: 10.1016/j.ajog.2012.10.884. Epub 2012 Oct 31.
Results Reference
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PubMed Identifier
22843002
Citation
Mercer JS, Erickson-Owens DA. Rethinking placental transfusion and cord clamping issues. J Perinat Neonatal Nurs. 2012 Jul-Sep;26(3):202-17; quiz 218-9. doi: 10.1097/JPN.0b013e31825d2d9a.
Results Reference
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Effect of Umbilical Cord Milking on Iron Related Health Outcomes for Cesarean-Delivered Infants

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