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

March 15, 2020 updated by: Jianmeng Liu, Peking University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

484

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410008
        • Hunan Provincial Maternal and Child Health Care Hospital
      • Liuyang, Hunan, China, 410399
        • Liuyang Maternal and Child Health Care Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
At birth (baseline), 1, 6 and 12 months after birth
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.
At birth (baseline), 1, 6 and 12 months after birth
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.
At birth (baseline), 1, 6 and 12 months after birth
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.
At birth (baseline), 1, 6, 12 and 18 months after birth
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.
At birth (baseline), 1, 6, 12 and 18 months after birth
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).
18 months old
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).
18 months old
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.
1 (baseline), 2, 3, 4 and 5 days after birth
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.
Up to 18 months old
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.
Up to 18 months old

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

August 23, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 15, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81571517

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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