The Hematologic Impact of Umbilical Cord Milking Versus Deferred Cord Clamping in Premature Neonates.

Preterm Neonates Clinical Trial

Official title:

The Hematologic Impact of Umbilical Cord Milking Versus Deferred Cord Clamping in Premature Neonates. A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03147846
• Other study ID #: milking vs delayed clamping
• Status: Completed
• Phase: N/A
• Start date: June 8, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: March 2020
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparing the beneficial effect of cord milking versus deferred cord clamping in preterm neonates. A randomized controlled trial

Description:

Placental transfusion either by deferred cord clamping or umbilical cord milking became standard care and recommended management especially in preterm deliveries.1 In average, about 80 ml of blood was found to be transferred to the neoborn by one minute after birth.2 This additional blood can afford extra iron and blood volume giving the benefit of less iron deficiency anemia during the first year of life, less need for blood transfusion, less need for vasopressors and less intraventricular hemorrhage (IVH) by 50%.3 Placental transfusion with different techniques proved safety with no significant risks regarding postpartum hemorrhage, polycythemia, jaundice, Apgar score or admission rates.4 Our study aims to compare delayed cord clamping with umbilical cord milking as the best way for placental transfusion for preterm neonates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Weeks to 35 Weeks

Eligibility

Inclusion Criteria:

• Gestational age 24 to 34+6 weeks

Exclusion Criteria:

• Category III CTG

• Monochorionic twins

• Significant antepartum hemorrhage

• IUGR or Rh incompatibility

Related Conditions & MeSH terms

• Delayed Cord Clamping
• Premature Birth
• Preterm Neonates
• Umbilical Cord Milking

Intervention

Procedure:
• delayed cord clamping
delay of cord clamping for 60 seconds
• cord milking
active cord milking 5 times

Locations

Country	Name	City	State
Saudi Arabia	Armed Forces Hospital of Southern Region	Khamis Mushait

Sponsors (2)

Lead Sponsor	Collaborator
Zagazig University	Armed Forces Hospitals, Southern Region, Saudi Arabia

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hematological parameters of the premature neonates	first draw and peak hematocrit value and hemoglobin percent, need for inotropes and blood transfusion	12 months
Secondary	composite neonatal morbidities	incidence of intraventricular hemorrhage, necrotizing enterocolitis, retinopathy, jaundice, sepsis , patent ductus arteriosus, etc	12 month