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Completed

NCT Number: NCT02092103

Delayed Clamping and Milking the Umbilical Cord in Preterm Infants

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.

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Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Good Samaritan TriHealth Hospital

Cincinnati, Ohio, 45220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cord Milking

Procedure

See description in cord milking arm.

Primary outcomes

  1. Hemoglobin and Hematocrit values (H/H) in NICU

    Time frame: NICU admission to discharge, expected average of 50 days

    All H/H values in the neonatal intensive care unit (NICU) will be recorded.

Secondary outcomes

  1. Neonatal transfusions

    Time frame: Birth to discharge, expected average of 50 days

    The incidence of transfusions between the two groups will be compared.

  2. Necrotizing enterocolitis

    Time frame: Birth to discharge, expected average of 50 days

    The incidence of necrotizing enterocolitis between the two groups will be compared.

  3. Intraventricular hemorrhage

    Time frame: Birth to discharge, expected average of 50 days

    The incidence of intraventricular hemorrhage between the two groups will be compared.

Other outcomes

  1. Length of stay

    Time frame: Birth to discharge, expected average of 50 days

    The length of NICU stay between the two arms will be compared.

  2. Survival to discharge

    Time frame: Birth to discharge, expected average of 50 days

    The rate of infant survival until discharge will be recorded for both groups.

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

Delayed Clamping and Milking the Umbilical Cord Prior to Clamping in Preterm Infants and the Effect of Neonatal Outcomes

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 19, 2014
Registry last updated
Dec 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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