Cord Milking in Elective Cesarean Section
Efficacy of Umbilical Cord Milking in Elective Cesarean Section
1 other identifier
observational
130
1 country
1
Brief Summary
The objective of the study was to investigate the efficacy and safety of umbilical cord milking as compared with immediate cord clamping on placental transfusion, estimated by Δ hematocrit between cord blood at birth and capillary heel hematocrit at 48 hours of age, in elective cesarean delivered neonates.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2018
Shorter than P25 for all trials
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
September 11, 2018
CompletedFirst Posted
Study publicly available on registry
September 13, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2019
CompletedSeptember 13, 2018
September 1, 2018
4 months
September 11, 2018
September 11, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Placental transfusion
Δ hematocrit between cord blood at birth and capillary heel hematocrit at 48 hours of age
48 hours
Study Arms (2)
immediate cord clamping
Tthe umbilical cord of neonates was cut and clamped.
umbilical cord milking.
Tthe umbilical cord of neonates was milked.
Interventions
The babies were held at the level of the placenta, while the umbilical cord was milked or cut and clamped.
Eligibility Criteria
All women who presented for an elective cesarean section were screened for eligibility.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Policlinico Abano Terme
Abano Terme, Italy
Related Publications (1)
Zanardo V, Guerrini P, Severino L, Simbi A, Parotto M, Straface G. A Randomized Controlled Trial of Intact Cord Milking versus Immediate Cord Clamping in Term Infants Born by Elective Cesarean Section. Am J Perinatol. 2021 Mar;38(4):392-397. doi: 10.1055/s-0039-1697673. Epub 2019 Oct 10.
PMID: 31600796DERIVED
Biospecimen
After the infant was delivered, the obstetrician either immediately clamped and cut the cord or initiated the milking protocol intervention, near the cord insertion site on the placenta towards the infant, three times before clamping.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Perinatal Medicine
Study Record Dates
First Submitted
September 11, 2018
First Posted
September 13, 2018
Study Start
October 1, 2018
Primary Completion
January 31, 2019
Study Completion
February 28, 2019
Last Updated
September 13, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share