Deferred Cord Clamping Compared to Umbilical Cord Milking in Preterm Infants

NCT ID: NCT02996799

Last Updated: 2022-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2023-06-30

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.

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.

Conditions

PreTerm Birth; Intraventricular Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Umbilical cord milking

Manually stripping 20cm of cord segment toward the umbilicus over a period of 2-3 seconds three times before cord clamping.

Group Type: EXPERIMENTAL

Umbilical cord milking

Intervention Type: OTHER

Milking of the umbilical cord at delivery

Interventions

Umbilical cord milking

Milking of the umbilical cord at delivery

Intervention Type: OTHER

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Abdulaziz University

OTHER

Sponsor Role: lead

Responsible Party

Heidi Al-Wassia

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heidi Al-Wassia, MD

Role: PRINCIPAL_INVESTIGATOR

King Abdulaziz University

Locations

King Abdulaziz University Hospital

Jeddah, , Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Heidi Al-Wassia

Role: CONTACT

halwassia@kau.edu.sa

966544800441

Facility Contacts

Heidi Al-Wassia

Role: primary

halwassia@kau.edu.sa

Other Identifiers

409-16

Identifier Type: -

Identifier Source: org_study_id