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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03147846
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : May 10, 2017
Armed Forces Hospitals, Southern Region, Saudi Arabia
Information provided by (Responsible Party):
Hytham Atia, Zagazig University

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

Condition or disease Intervention/treatment Phase
Delayed Cord Clamping Umbilical Cord Milking Preterm Neonates Procedure: delayed cord clamping Procedure: cord milking Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: closed envelop method
Primary Purpose: Prevention
Official Title: The Hematologic Impact of Umbilical Cord Milking Versus Deferred Cord Clamping in Premature Neonates. A Randomized Controlled Trial
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : January 1, 2018
Estimated Study Completion Date : March 1, 2018

Arm Intervention/treatment
Experimental: 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

Procedure: delayed cord clamping
delay of cord clamping for 60 seconds

Active Comparator: 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
Procedure: cord milking
active cord milking 5 times

Primary Outcome Measures :
  1. hematological parameters of the premature neonates [ Time Frame: 12 months ]
    hematocrite value

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Ages Eligible for Study:   24 Weeks to 35 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

• Gestational age 24 to 34+6 weeks

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03147846

Contact: Mohamed K Gomaa, MD 00966/0501783606
Contact: Hytham Atia, MD 00966/0538308500

Saudi Arabia
Armed Forces Hospital of Southern Region Recruiting
Khamis Mushait, Saudi Arabia, 61961
Contact: Mohamed Gomaa, MD    0966/0501783606   
Contact: Hytham Atia, MD    0966/538308500   
Principal Investigator: Mohamed Gomaa, MD         
Principal Investigator: Hytham Atia, MD         
Sponsors and Collaborators
Zagazig University
Armed Forces Hospitals, Southern Region, Saudi Arabia

Responsible Party: Hytham Atia, lecturer, Zagazig University Identifier: NCT03147846     History of Changes
Other Study ID Numbers: milking vs delayed clamping
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications