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

Not Applicable

Completed

• Conditions: Delayed Cord Clamping; Preterm Neonates; Umbilical Cord Milking
• Interventions: Procedure: delayed cord clamping; Procedure: cord milking

• Registration Number: NCT03147846
• Lead Sponsor: Zagazig University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-04-29
• Study First Submitted QC: 2017-05-07
• Study First Posted: 2017-05-10
• Study Start: 2017-06-08
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Gestational age 24 to 34+6 weeks

Exclusion Criteria

• Category III CTG
• Monochorionic twins
• Significant antepartum hemorrhage
• IUGR or Rh incompatibility

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
delayed cord clamping	delayed cord clamping	Keep the baby at the level or below the placenta for 45-60 seconds before clamping the cord. Keep the room temperature at 23-25˚C and wrap the baby if possible
cord milking	cord milking	Do 4-5 strips from proximal (maternal) end of the cord (as proximal as possible) towards the baby abdomen with thumb and forefinger Wait for 2 seconds between each stripping Keep the baby at the level of placenta

Primary Outcome Measures

Name	Time	Method
hematological parameters of the premature neonates	12 months	first draw and peak hematocrit value and hemoglobin percent, need for inotropes and blood transfusion

Secondary Outcome Measures

Name	Time	Method
composite neonatal morbidities	12 month	incidence of intraventricular hemorrhage, necrotizing enterocolitis, retinopathy, jaundice, sepsis , patent ductus arteriosus, etc

Trial Locations

Locations (1)

Armed Forces Hospital of Southern Region; 🇸🇦 Khamis Mushait, Saudi Arabia