Deferred Cord Clamping Compared to Umbilical Cord Milking in Preterm Infants

NCT02996799 | Unknown DMC

• 1 other identifier: 409-16
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

PreTerm Birth; Intraventricular Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Intraventricular haemorrhage

  Any IVH diagnosed by cranial ultrasound

  twenty eight days

Secondary Outcomes (20)

• Need for resuscitation

  one hour

• Apgar score at one minute

  one minute after delivery

• Apgar score at 5 minutes

  5 minutes after delivery

• The need for blood transfusion during hospital stay

  one month

• Venous Hgb

  2 days

Study Arms (2)

Deferred Cord Clamping

NO INTERVENTION

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.

Umbilical cord milking

EXPERIMENTAL

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

Interventions

Umbilical cord milking OTHER

Milking of the umbilical cord at delivery

Umbilical cord milking

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University Hospital

Jeddah, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Heidi Al-Wassia, MD

  King Abdulaziz University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidi Al-Wassia

CONTACT

966544800441; halwassia@kau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 3, 2016
• First Posted: December 19, 2016
• Study Start: January 1, 2017
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 18, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available upon request
• Access Criteria: Shared files

Locations

SA (1)