The Hematologic Impact of Umbilical Cord Milking Versus Deferred Cord Clamping in Premature Neonates.
1 other identifier
interventional
200
1 country
1
Brief Summary
Comparing the beneficial effect of cord milking versus deferred cord clamping in preterm neonates. A randomized controlled trial
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2017
CompletedFirst Posted
Study publicly available on registry
May 10, 2017
CompletedStudy Start
First participant enrolled
June 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedMarch 31, 2020
March 1, 2020
2.2 years
April 29, 2017
March 30, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
hematological parameters of the premature neonates
first draw and peak hematocrit value and hemoglobin percent, need for inotropes and blood transfusion
12 months
Secondary Outcomes (1)
composite neonatal morbidities
12 month
Study Arms (2)
delayed cord clamping
EXPERIMENTALKeep 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
ACTIVE COMPARATORDo 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
Interventions
Eligibility Criteria
You may qualify if:
- Gestational age 24 to 34+6 weeks
You may not qualify if:
- Category III CTG
- Monochorionic twins
- Significant antepartum hemorrhage
- IUGR or Rh incompatibility
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Armed Forces Hospital of Southern Region
Khamis Mushait, 61961, Saudi Arabia
Related Publications (1)
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.
PMID: 36123638DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hytham Atia, MD
Armed forces hospitals Southern Region KSA
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- closed envelop method
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer
Study Record Dates
First Submitted
April 29, 2017
First Posted
May 10, 2017
Study Start
June 8, 2017
Primary Completion
September 1, 2019
Study Completion
September 1, 2019
Last Updated
March 31, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share