NCT03023917

Brief Summary

The overall objective of the present study is to examine the effects of umbilical cord milking at birth in preterm infants to prevent and decrease anemia using a multi-center prospective randomized controlled trial comparing immediate cord clamping (standard at present) with umbilical cord milking.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
284

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

June 30, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

2.2 years

First QC Date

January 3, 2017

Last Update Submit

October 24, 2020

Conditions

Anemia

Keywords

umbilical cord milking;anemia;placental transfusion

Outcome Measures

Primary Outcomes (3)

  • concentrations of Hemoglobin (Hb)

    48 hours after birth

  • concentrations of Hematocrit(Hct)

    48 hours after birth

  • serum ferritin level

    48 hours after birth

Secondary Outcomes (4)

  • Hyperbilirubinemia requiring phototherapy

    during first 2 weeks of age

  • incidence and numbers of blood transfusions

    until 3 months corrected gestational age

  • Length of admission

    Birth to discharge, expected average of 30 days

  • complication

    Birth to discharge, expected average of 30 days

Study Arms (2)

umbilical cord clamping immediately

ACTIVE COMPARATOR

Umbilical cord was clamped immediately, or as close as possible, after delivery of the infant's shoulders. (This was standard practice in the study hospital, thus it served as the "control" group).

Procedure: umbilical cord clamping immediately

umbilical cord milking

EXPERIMENTAL

preterm baby were placed at or below level of the placenta and about 25cm of the umbilical cord was vigorously milked towards the umbilicus two to three times before clamping the cord. The milking speed was about 25cm/2 seconds

Procedure: umbilical cord milking

Interventions

umbilical cord milkingPROCEDURE

Infants were placed at or below level of the placenta and about 25cm of the umbilical cord was vigorously milked towards the umbilicus two to three times before clamping the cord. The milking speed was about 25cm/2 seconds

umbilical cord milking
umbilical cord clamping immediatelyPROCEDURE

umbilical cord was cut immediately after birth

umbilical cord clamping immediately

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women in labour or with a plan for delivery at a gestational age less than 34 weeks gestation.
  • Singleton pregnancy
  • informed consent was obtained from the parent

You may not qualify if:

  • Multiple gestation
  • Diagnosis of any of the following in the current pregnancy: hemorrhage requiring clinic/hospital admission, placental abnormalities, fetal anomalies, Down's syndrome of the fetus,anemia
  • Diagnosis of pre-eclampsia or eclampsia in current or previous pregnancies
  • Diagnosis at any time for the mother of any of the following: serious Diabetes, serious hypertension, chronic renal disease
  • Infant with major congenital malformation
  • Infant with blood disease
  • Unwilling to return for follow-up study visits at the hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

Location

MeSH Terms

Conditions

Anemia

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • guangyu chen

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 3, 2017

First Posted

January 18, 2017

Study Start

June 30, 2017

Primary Completion

August 31, 2019

Study Completion

December 31, 2019

Last Updated

October 27, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)