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Delayed Clamping and Milking the Umbilical Cord in Preterm Infants

NCT ID: NCT02092103

Last Updated: 2018-12-28

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

COMPLETED

Clinical Phase

NA

Total Enrollment

282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2018-07-08

Brief Summary

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This is a randomized controlled trial that will compare the effects of delayed umbilical cord clamping to umbilical cord milking in preterm infants (less than 34 weeks gestation). The infants' hemoglobin and hematocrit levels in the Neonatal Intensive Care Unit (NICU) will be evaluated, as well as the rates of necrotizing enterocolitis, intraventricular hemorrhage, and blood transfusions. The hypothesis is that milking the umbilical cord prior to clamping is superior to simply delayed cord clamping, presumably providing an increased blood volume to the preterm neonate improving its outcomes.

Detailed Description

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The optimal timing for clamping the umbilical cord after birth in preterm infants has been a subject of controversy and debate for many years. It has been until recently the standard practice in ob/gyn to clamp the umbilical cord immediately post delivery to allow for immediate transition resuscitation of the neonate, especially in preterm infants. Due to the fact that optimal timing for cord clamping has yet to be definitively established in the preterm population, more information is needed. Immediate cord clamping, however, could preclude the infant from an extra boost in blood volume that may prove beneficial later in the newborn life. Directly comparing the recently recommended practice of delayed umbilical cord clamping to milking the umbilical cord prior to clamping has the potential to prove beneficial for the neonates in question, as well as change daily obstetrical practices. In this study all infants below 34 weeks will be randomized into one of two groups: delayed cord clamping and milking the umbilical cord prior to clamping. The decision was made not to include immediate cord clamping due to a recent American Congress of Obstetricians and Gynecologists (ACOG) recommendation that all preterm infants have their cord clamping be delayed. Their outcomes will be measured by serial hemoglobin and hematocrit levels while in the NICU, the incidence of necrotizing enterocolitis, incidence of intraventricular hemorrhage, and the need for neonatal blood transfusions.

Conditions

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Premature Birth

Keywords

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Premature Birth Umbilical Cord Clamping

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Delayed Clamping

The American Congress of Obstetricians and Gynecologists (ACOG) recommends delayed cord clamping for preterm infants. Infants randomized to this group will follow the protocol below:

1. Infant held at or below level of perineum (vaginal delivery) or incision (cesarean delivery)
2. Once infant is delivered designated RN starts timer
3. Infant warming bag on delivery table
4. Infant placed into warming bag then wrapped in a towel
5. Assistant to deliver preps cord clamps
6. Registered Nurse (RN) notifies provider at 30 seconds
7. Cord clamped and cut
8. Infant handed off to waiting staff
9. Exceptions: Placental separation, cord stops pulsating, need for immediate resuscitation, all would result in clamping prior to 30 seconds

Group Type NO_INTERVENTION

No interventions assigned to this group

Cord Milking

Infants randomized to the cord milking group will follow the protocol below:

1. Infant held at or below level of perineum (vaginal delivery) or incision (cesarean delivery)
2. Infant held and the cord is milked from perineum to infant four times
3. Assistant to deliver preps cord clamps
4. Cord clamped and cut
5. Infant handed off to waiting staff

Group Type EXPERIMENTAL

Cord Milking

Intervention Type PROCEDURE

See description in cord milking arm.

Interventions

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Cord Milking

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Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Admitted to Labor \& Delivery at Good Samaritan TriHealth Hospital in Cincinnati, Ohio with expected/possible preterm delivery between 23-34 weeks gestation
* Care provided by Good Samaritan TriHealth Hospital's Faculty Medical Center or Tri-State Maternal Fetal Medicine

Exclusion Criteria

* Declined to participate
* Known congenital anomalies
* Precipitous delivery preventing completion of the protocol
* Placental abruption around the time of or as indication for delivery
* Mother has uterine rupture
* Non reassuring fetal heart tracing (FHT) immediately prior/leading to delivery
* Multiple gestation
* Parvo B19
* Infants known to be at risk of anemia due to isoimmunization (mother has red blood cell antibodies
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TriHealth Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathleen Smith, MD PhD

Role: PRINCIPAL_INVESTIGATOR

TriHealth Inc.

Locations

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Good Samaritan TriHealth Hospital

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23168790 (View on PubMed)

Other Identifiers

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13094-14-012

Identifier Type: -

Identifier Source: org_study_id