Deferred Cord Clamping Compared to Umbilical Cord Milking in Preterm Infants

Efficacy and Safety of Deferred Umbilical Cord Clamping Compared to Umbilical CordMilking in Preterm Infants: A Randomized Clinical Trial

For preterm infants, deferred cord clamping has been shown to improve both short term and long-term neonatal outcomes without an established harm for both the mother and her infant.The interference with resuscitative measures for the neonate or the mother is a risk that continued to hamper the implementation of delayed cord clamping in many centers around the world.For that reason, the evidence now is seeking a time-honored, yet not adopted method of placental transfusion that involves milking of the umbilical cord.

Study Overview

• Status: Recruiting
• Conditions: Intraventricular Hemorrhage; PreTerm Birth
• Intervention / Treatment: Other: Umbilical cord milking

Detailed Description

Contrary to delayed cord clamping, milking of the umbilical cord is done at a faster rate and in shorter time.Recent evidence has demonstrated the efficacy and safety of umbilical cord milking for both term and preterm infants.A newer evidence comparing delayed cord clamping to umbilical cord milking in preterm infants demonstrated a higher initial hemoglobin, blood pressure and systemic blood flow in preterm infants allocated to the umbilical cord milking arm.However, concerns have been raised with regard to rapid infusion of large volume of blood in relatively shorter time predisposing to hyperperfusion injury including intraventricular hemorrhage. This is particularly problematic for preterm neonates as they are at higher risk of neurological injury. It has, though, advantage of shorter timeframe allowing for effective resuscitation of preterm neonates to start as soon as possible. Thus, with countering advantages and disadvantages, the practice has not been adopted at most places. The authors planned to conduct a randomized clinical trail to compare the efficacy and safety of umbilical cord milking to deferred cord clamping in preterm infants less than 32 weeks gestation.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heidi Al-Wassia; Phone Number: 966544800441; Email: halwassia@kau.edu.sa

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia
    • Recruiting
    • King AbdulAziz University Hospital
    • Contact: Heidi Al-Wassia; Email: halwassia@kau.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Preterm infants < 32 weeks gestation confirmed by first trimester US

Exclusion Criteria:

• Any proven or suspected congenital or chromosomal abnormalities
• Placenta previa or abruption
• Cord prolapse
• Known Rh sensitization
• Fetal hydrops
• Monochorionic multiples

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Deferred Cord Clamping; Neonate is held at the level of placenta (level of introitus (vaginal delivery ) and mother's thigh or operating table (C/S) and cord clamping is deferred for 60 seconds.
EXPERIMENTAL: Umbilical cord milking; Manually stripping 20cm of cord segment toward the umbilicus over a period of 2-3 seconds three times before cord clamping.	Other: Umbilical cord milking; Milking of the umbilical cord at delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraventricular haemorrhage	Any IVH diagnosed by cranial ultrasound	twenty eight days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for resuscitation	Cardiac compression or medications at birth	one hour
Apgar score at one minute	Calculated Apgar score at one minute	one minute after delivery
Apgar score at 5 minutes	Calculated Apgar score at 5 minutes	5 minutes after delivery
The need for blood transfusion during hospital stay	The number of blood transfusions during hospital stay	one month
Venous Hgb	Hgb at birth	2 days
Venous hematocrit	Hematocrit at birth	2 days
Bilirubin level	First bilirubin level after birth	24 hours after birth
Maximum bilirubin level	Highest bilirubin level	first week of life
Polycythemia	If venous hematocrit more than 65%	first 48 hours after birth
Respiratory distress syndrome	The need for surfactant administration	48 hours after birth
Oxygen dependency	first 28 days after birth and/or 36 weeks corrected age	first 28 days after birth and 36 weeks corrected age
Need for volume administration	Need for bolus administration first 24 hours after birth	24 hours after birth
Use of inotropes	Use of any kind of inotropes in the first 24 hours	First 24 hours
Necrotizing enterocolitis	Bell stage II or more	one month
Mortality in hospital	Death before discharge	one month
Sepsis	Positive blood culture	one month
Maternal mortality	Maternal death after delivery in hospital	2 weeks
Post partum hemorrhage	Maternal estimated blood loss more than 500 mls in the first 24 hours after birth	one day
Maternal need for blood transfusion	Maternal blood transfusion in the first 48 hours after delivery	First 48 hours after delivery
Length of third stage	The time from delivery of the infant until delivery of placenta	24 hours

Collaborators and Investigators

• Sponsor: King Abdulaziz University
• Investigators: Principal Investigator: Heidi Al-Wassia, MD, King Abdulaziz University

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: December 3, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (ESTIMATE): December 19, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Hemorrhage; Premature Birth
• Other Study ID Numbers: 409-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We are planning to publish all the data that we will collect. If other researchers have specific questions about the data, we are willing to answer and share if needed.
• IPD Sharing Time Frame: Data will be available upon request
• IPD Sharing Access Criteria: Shared files
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL