NCT01523769

Brief Summary

Delayed cord clamp of at least 30 seconds in neonates under 37 weeks has shown that these infants have higher circulating blood volume in the first 24 hours, less need for blood transfusions, and less incidence of intraventricular hemorrhage. Delayed umbilical cord clamping has also been shown to increase the initial hematocrit and decrease the need for red blood cell (RBC) transfusions compared with no intervention in infants born between 27 and 33 weeks' gestation. However, a delay in cord clamping of 30-45 seconds may theoretically interfere with neonatal resuscitation. There have been few studies that addressed the active milking of the cord and its effect on neonatal resuscitation. Active milking of the umbilical cord towards the baby prior to clamping (rather than passive) should take less than 5 seconds to perform and should not interfere with neonatal resuscitation. Umbilical cord milking, as an alternative to delayed cord clamping, has been shown to increase the circulatory blood volume expressed as the hemoglobin value. Active milking of the cord prior to clamping, however, is not considered standard of care and only 1 Japanese randomized control study has reported that umbilical cord milking reduces the need for RBC transfusions, thus reducing the number of infants requiring a RBC transfusion as compared with control conditions. Our study aims to test the hypothesis that active milking of the umbilical cord will reduce the need for transfusion in preterm infants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2009

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

Study Start

First participant enrolled

September 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
Last Updated

February 1, 2012

Status Verified

January 1, 2012

Enrollment Period

2.2 years

First QC Date

December 16, 2011

Last Update Submit

January 30, 2012

Conditions

Prematurity

Keywords

prematurityumbilical cord milkingdelayed cord clampingneonatal transfusion

Outcome Measures

Primary Outcomes (1)

  • Red blood cell transfusion

    need for packed red blood cell transfusion in the first 28 days of neonatal life

    28 days

Secondary Outcomes (19)

  • Volume of blood transfusion

    28 days

  • Intraventricular Hemorrhage

    28 days

  • Days until transfusion

    28 days

  • Respiratory Distress Syndrome

    28 days

  • Retinopathy of Prematurity

    28 days

  • +14 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Control group, the cord was not milked

Umbilical Cord Milking

EXPERIMENTAL

Approximately 10 cm of umbilical cord was milked toward the baby immediately following delivery

Procedure: Umbilical Cord Milking

Interventions

Umbilical Cord MilkingPROCEDURE

Approximately 10 cm of umbilical cord was milked toward the baby immediately following delivery. (The blood remaining in the umbilical cord after delivery is squeezed in the direction from the placenta (remaining inside the uterus) toward the newborn baby.)

Also known as: Umbilical Cord Milking, autotransfusion
Umbilical Cord Milking

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Singleton pregnancy
  • Delivery anticipated between 24 and 28+6 weeks gestation
  • There is enough time from admission to anticipated delivery to properly obtain consent from the patient

You may not qualify if:

  • Multifetal gestation
  • Antenatally diagnosed major congenital anomaly
  • Known Rh sensitized pregnancy
  • Hydrops fetalis (any etiology)
  • Known positive maternal Parvovirus titers
  • Elevated peak systolic velocity of the fetal Middle Cerebral Artery (MCA)
  • Clinical suspicion of placental abruption at delivery due to excessive maternal bleeding or uterine hypertonicity
  • Maternal age under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Umbilical Cord ClampingBlood Transfusion, Autologous

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, OperativeBlood TransfusionBiological TherapyTherapeutics

Study Officials

  • Margarita deVeciana, MD

    Eastern Virginia Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2011

First Posted

February 1, 2012

Study Start

September 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

February 1, 2012

Record last verified: 2012-01

Locations

US(1)