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

Primary Purpose

Delayed Cord Clamping, Umbilical Cord Milking, Preterm Neonates

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
delayed cord clamping
cord milking
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delayed Cord Clamping

Eligibility Criteria

24 Weeks - 35 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

• Gestational age 24 to 34+6 weeks

Exclusion Criteria:

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

Sites / Locations

  • Armed Forces Hospital of Southern Region

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

delayed cord clamping

cord milking

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

composite neonatal morbidities
incidence of intraventricular hemorrhage, necrotizing enterocolitis, retinopathy, jaundice, sepsis , patent ductus arteriosus, etc

Full Information

First Posted
April 29, 2017
Last Updated
March 30, 2020
Sponsor
Zagazig University
Collaborators
Armed Forces Hospitals, Southern Region, Saudi Arabia
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1. Study Identification

Unique Protocol Identification Number
NCT03147846
Brief Title
The Hematologic Impact of Umbilical Cord Milking Versus Deferred Cord Clamping in Premature Neonates.
Official Title
The Hematologic Impact of Umbilical Cord Milking Versus Deferred Cord Clamping in Premature Neonates. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 8, 2017 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
Collaborators
Armed Forces Hospitals, Southern Region, Saudi Arabia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Cord Clamping, Umbilical Cord Milking, Preterm Neonates

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
closed envelop method
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
delayed cord clamping
Arm Type
Experimental
Arm Description
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
Arm Title
cord milking
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
delayed cord clamping
Intervention Description
delay of cord clamping for 60 seconds
Intervention Type
Procedure
Intervention Name(s)
cord milking
Intervention Description
active cord milking 5 times
Primary Outcome Measure Information:
Title
hematological parameters of the premature neonates
Description
first draw and peak hematocrit value and hemoglobin percent, need for inotropes and blood transfusion
Time Frame
12 months
Secondary Outcome Measure Information:
Title
composite neonatal morbidities
Description
incidence of intraventricular hemorrhage, necrotizing enterocolitis, retinopathy, jaundice, sepsis , patent ductus arteriosus, etc
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Weeks
Maximum Age & Unit of Time
35 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Gestational age 24 to 34+6 weeks Exclusion Criteria: Category III CTG Monochorionic twins Significant antepartum hemorrhage IUGR or Rh incompatibility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hytham Atia, MD
Organizational Affiliation
Armed forces hospitals Southern Region KSA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Armed Forces Hospital of Southern Region
City
Khamis Mushait
ZIP/Postal Code
61961
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36123638
Citation
Atia H, Badawie A, Elsaid O, Kashef M, Alhaddad N, Gomaa M. The hematological impact of umbilical cord milking versus delayed cord clamping in premature neonates: a randomized controlled trial. BMC Pregnancy Childbirth. 2022 Sep 19;22(1):714. doi: 10.1186/s12884-022-05046-7.
Results Reference
derived

Learn more about this trial

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

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