Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate

Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate - a Randomized, Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Premature Birth
• Intervention / Treatment: Procedure: Delayed cord clamping; Procedure: Milking of the cord

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Delayed cord clamping; Delayed cord clamping for 30 seconds	Procedure: Delayed cord clamping; Delay cord clamping for 30 seconds after birth
Experimental: Milking of the cord; Milking of the cord 4 times in 10 seconds	Procedure: Milking of the cord; Milking of the cord 4 times in 10 seconds
No Intervention: Immediate cord clamping; Immediate cord clamping after delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Neonatal Event	composite of bronchopulmonary dysplasia (BPD), necrotising eneterocolitis (NEC), grade 3 or 4 intraventricular hemorrhage (IVH) or periventricular leukomalacia (PVL), or death prior to discharge home	up to 24 weeks after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe intraventricular hemorrhage (grade 3 or 4)		up to 24 weeks after birth
Phototherapy	Requirement and length of phototherapy	up to 24 weeks after birth
Ionotropic support	Requirement and length of ionotropic support	up to 24 weeks after birth
Necrotizing enterocolitis		up to 24 weeks after birth
Number of blood transfusions while in the neonatal intensive care unit		up to 24 weeks after birth
Ventilator time		up to 24 weeks after birth
Apgar score <7 at 5 minutes		at 5 minutes after birth
Umbilical cord pH < 7.0		up to 30 minutes after birth
Polycythemia		up to 24 hours of life
Neonatal death		up to 24 weeks of life
Use of uterotonic agents		up to 1 hour after birth
Maternal estimated blood loss	Estimated blood loss at delivery	up to 1 hour after delivery
Any grade intraventricular hemorrhage		up to 24 weeks after birth
Periventricular leukomalacia		up to 24 weeks after birth
Bronchopulmonary dysplasia		up to 24 weeks after birth
Peak transcutaneous and/or serum bilirubin concentrations		up to 24 weeks after birth
Neonatal intesive care unit (NICU) length of stay		up to 24 weeks after birth
Sepsis		up to 24 weeks after birth
Respiratory distress syndrome		up to 24 weeks after birth
Blood pressure on admission to neonatal intensive care unit		at 30 minutes after birth
Hematocrit on admission to neonatal intensive care unit		up to 4 hours after birth
Length of 3rd stage of labor	Time period between delivery of the baby and delivery of the placenta	up to 1 hour after birth
Maternal blood transfusion		up to 5 days after delivery
Manual removal of placenta		up to 1 hour after birth
Operating time for cesarean delivery		up to 3 hours after birth

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute
• Investigators: Principal Investigator: Rita W Driggers, MD, Washington Hospital Center, Georgetown University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: June 1, 2011
• First Submitted That Met QC Criteria: July 12, 2011
• First Posted (Estimate): July 13, 2011

Study Record Updates

• Last Update Posted (Estimate): February 22, 2013
• Last Update Submitted That Met QC Criteria: February 20, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Umbilical cord; Preterm; Delayed cord clamping; Cord milking
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 2011-053