Delayed Clamping and Milking the Umbilical Cord in Preterm Infants

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

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.

Study Overview

• Status: Completed
• Conditions: Premature Birth
• Intervention / Treatment: Procedure: Cord Milking

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 282
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan TriHealth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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: Infant held at or below level of perineum (vaginal delivery) or incision (cesarean delivery); Once infant is delivered designated RN starts timer; Infant warming bag on delivery table; Infant placed into warming bag then wrapped in a towel; Assistant to deliver preps cord clamps; Registered Nurse (RN) notifies provider at 30 seconds; Cord clamped and cut; Infant handed off to waiting staff; Exceptions: Placental separation, cord stops pulsating, need for immediate resuscitation, all would result in clamping prior to 30 seconds
Experimental: Cord Milking; Infants randomized to the cord milking group will follow the protocol below: Infant held at or below level of perineum (vaginal delivery) or incision (cesarean delivery); Infant held and the cord is milked from perineum to infant four times; Assistant to deliver preps cord clamps; Cord clamped and cut; Infant handed off to waiting staff	Procedure: Cord Milking; See description in cord milking arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin and Hematocrit values (H/H) in NICU	All H/H values in the neonatal intensive care unit (NICU) will be recorded.	NICU admission to discharge, expected average of 50 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal transfusions	The incidence of transfusions between the two groups will be compared.	Birth to discharge, expected average of 50 days
Necrotizing enterocolitis	The incidence of necrotizing enterocolitis between the two groups will be compared.	Birth to discharge, expected average of 50 days
Intraventricular hemorrhage	The incidence of intraventricular hemorrhage between the two groups will be compared.	Birth to discharge, expected average of 50 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	The length of NICU stay between the two arms will be compared.	Birth to discharge, expected average of 50 days
Survival to discharge	The rate of infant survival until discharge will be recorded for both groups.	Birth to discharge, expected average of 50 days

Collaborators and Investigators

• Sponsor: TriHealth Inc.
• Investigators: Principal Investigator: Kathleen Smith, MD PhD, TriHealth Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): July 8, 2018
• Study Completion (Actual): July 8, 2018

Study Registration Dates

• First Submitted: March 13, 2014
• First Submitted That Met QC Criteria: March 17, 2014
• First Posted (Estimate): March 19, 2014

Study Record Updates

• Last Update Posted (Actual): December 28, 2018
• Last Update Submitted That Met QC Criteria: December 27, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Premature Birth; Umbilical Cord Clamping
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 13094-14-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO