Deferred Cord Clamping Compared to Umbilical Cord Milking in Preterm Infants

• ClinicalTrials.gov Identifier: NCT02996799
• Recruitment Status: Recruiting
• First Posted: December 19, 2016
• Last Update Posted: March 7, 2018
• Sponsor: King Abdulaziz University
• Information provided by (Responsible Party): Heidi Al-Wassia, King Abdulaziz University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
PreTerm Birth; Intraventricular Hemorrhage	Other: Umbilical cord milking	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Efficacy and Safety of Deferred Umbilical Cord Clamping Compared to Umbilical CordMilking in Preterm Infants: A Randomized Clinical Trial
• Study Start Date: January 2017
• Estimated Primary Completion Date: January 2019
• Estimated Study Completion Date: January 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Intraventricular haemorrhage [ Time Frame: twenty eight days ]

Secondary Outcome Measures :

1. Need for resuscitation [ Time Frame: one hour ]
2. Apgar score at one minute [ Time Frame: one minute after delivery ]
3. Apgar score at 5 minutes [ Time Frame: 5 minutes after delivery ]
4. The need for blood transfusion during hospital stay [ Time Frame: one month ]
5. Venous Hgb [ Time Frame: 2 days ]
6. Venous hematocrit [ Time Frame: 2 days ]
7. Bilirubin level [ Time Frame: 24 hours after birth ]
8. Maximum bilirubin level [ Time Frame: first week of life ]
9. Polycythemia [ Time Frame: first 48 hours after birth ]
10. Respiratory distress syndrome [ Time Frame: 48 hours after birth ]
11. Oxygen dependency [ Time Frame: first 28 days after birth and 36 weeks corrected age ]
12. Need for volume administration [ Time Frame: 24 hours after birth ]
13. Use of inotropes [ Time Frame: First 24 hours ]
14. Necrotizing enterocolitis [ Time Frame: one month ]
15. Mortality in hospital [ Time Frame: one month ]
16. Sepsis [ Time Frame: one month ]
17. Maternal mortality [ Time Frame: 2 weeks ]
18. Post partum hemorrhage [ Time Frame: one day ]
19. Maternal need for blood transfusion [ Time Frame: First 48 hours after delivery ]
20. Length of third stage [ Time Frame: 24 hours ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Heidi Al-Wassia; 966544800441; halwassia@kau.edu.sa

Locations

Saudi Arabia

King Abdulaziz University Hospital; Recruiting

Jeddah, Saudi Arabia

Contact: Heidi Al-Wassia halwassia@kau.edu.sa

Sponsors and Collaborators

King Abdulaziz University

More Information

• Responsible Party: Heidi Al-Wassia, Assistant Professor, King Abdulaziz University
• ClinicalTrials.gov Identifier: NCT02996799 History of Changes
• Other Study ID Numbers: 409-16
• First Posted: December 19, 2016
• Last Update Posted: March 7, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• 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.

Additional relevant MeSH terms:

Premature Birth; Hemorrhage; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Pathologic Processes