Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate

NCT ID: NCT01393834

Last Updated: 2013-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-01-31

Brief Summary

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This study is being done to evaluate if delaying cord clamping or milking the umbilical cord of the preterm infant has health benefits for the baby. Timing of clamping of the cord varies among doctors, but there is information that shows that delaying clamping of the umbilical cord in premature infants may reduce the rate of the baby needing a blood transfusion, decrease the risk of infection and bleeding in the head.

Detailed Description

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Conditions

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Premature Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Delayed cord clamping

Delayed cord clamping for 30 seconds

Group Type EXPERIMENTAL

Delayed cord clamping

Intervention Type PROCEDURE

Delay cord clamping for 30 seconds after birth

Milking of the cord

Milking of the cord 4 times in 10 seconds

Group Type EXPERIMENTAL

Milking of the cord

Intervention Type PROCEDURE

Milking of the cord 4 times in 10 seconds

Immediate cord clamping

Immediate cord clamping after delivery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Delayed cord clamping

Delay cord clamping for 30 seconds after birth

Intervention Type PROCEDURE

Milking of the cord

Milking of the cord 4 times in 10 seconds

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Singleton or multiples pregnancies in patients admitted for medically indicated delivery or in advanced spontaneous preterm labor with imminent delivery at 24 0/7 - 28 6/7 weeks gestation
* Women ages 18 and older

Exclusion Criteria

* Planned vaginal breech delivery
* Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery)
* Fetal death in utero
* Red cell isoimmunization
* Patients who are incapable of informed consent (unconscious, severely ill, mentally handicapped), or are unwilling to undergo randomization
* Placenta previa or other known abnormal placentation (e.g. placenta accreta)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rita W Driggers, MD

Role: PRINCIPAL_INVESTIGATOR

Washington Hospital Center, Georgetown University Hospital

Other Identifiers

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2011-053

Identifier Type: -

Identifier Source: org_study_id

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