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Completed

NCT Number: NCT03147846

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

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

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Key information

Conditions

Delayed Cord Clamping Preterm Neonates Umbilical Cord Milking

Age range

24 week–35 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Armed Forces Hospital of Southern Region

Khamis Mushait, 61961, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational age 24 to 34+6 weeks

Exclusion criteria

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

Treatment and study plan

Delayed Cord Clamping

Procedure

delay of cord clamping for 60 seconds

Cord Milking

Procedure

active cord milking 5 times

Primary outcomes

  1. hematological parameters of the premature neonates

    Time frame: 12 months

    first draw and peak hematocrit value and hemoglobin percent, need for inotropes and blood transfusion

Secondary outcomes

  1. composite neonatal morbidities

    Time frame: 12 month

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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Collaborators

  • Armed Forces Hospitals, Southern Region, Saudi Arabia

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 10, 2017
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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