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Deferred Cord Clamping Compared to Umbilical Cord Milking in Preterm Infants

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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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




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 ]


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996799


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

Locations
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Saudi Arabia
King Abdulaziz University Hospital Recruiting
Jeddah, Saudi Arabia
Contact: Heidi Al-Wassia       halwassia@kau.edu.sa   
Sponsors and Collaborators
King Abdulaziz University

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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    Key Record Dates
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:
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Premature Birth
Hemorrhage
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Pathologic Processes