Hemodynamic Effects of Delayed Umbilical Cord Clamping in Full-term Newborns
1 other identifier
interventional
68
1 country
1
Brief Summary
The sequence of events at the time of delivery includes delivery of the infant, clamping of the umbilical cord, and lastly delivery of the placenta. There are some benefits for delayed cord clamping. This study aims to compare the effects of two different duration of delayed cord clamping. Infants will be randomized into two groups based on the duration of delayed cord clamping: 30 seconds vs 120 seconds. Different hemodynamic effects will be measured in each group at different time intervals. The hypothesis of the study is that delayed cord clamping for 120 seconds is associated with better cardiac output and with other hemodynamic advantages.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedFirst Submitted
Initial submission to the registry
April 18, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedApril 24, 2020
April 1, 2020
2 months
April 18, 2020
April 21, 2020
Conditions
Outcome Measures
Primary Outcomes (6)
Cardiac output
Data imported from the electrical cardiometry device
at 15 minutes
Stroke volume
Data imported from the electrical cardiometry device
at 15 minutes
Cardiac index
Data imported from the electrical cardiometry device
at 15 minutes
Index of contractility
Data imported from the electrical cardiometry device
at 15 minutes
Heart rate
Data imported from the electrical cardiometry device
at 15 minutes
Oxygen saturation
Data imported from the electrical cardiometry device
at 15 minutes
Secondary Outcomes (3)
Hemoglobin concentration
At 24 hours
Serum glucose concentration
At 24 hours
Serum bilirubin concentration
At 24 hours
Study Arms (2)
30 second cord clamping
ACTIVE COMPARATORInfants in this group will receive delayed cord clamping for 30 seconds.
120 second cord clamping
ACTIVE COMPARATORInfants in this group will receive delayed cord clamping for 120 seconds.
Interventions
The umbilical cord will be clamped after specific time intervals
Eligibility Criteria
You may qualify if:
- Normal full term newborns ≥37 weeks gestational age
- Both genders are included
- Singleton
- Delivered by elective cesarean section due to previous cesarean section, cephalo-pelvic disproportion, or mal-presentation
- Successfully transitioned without need for respiratory or medication support
You may not qualify if:
- Neonates needing any active resuscitation
- In-utero fetal distress
- Suspected perinatal asphyxia
- Major congenital malformations
- Twin or multiple gestation
- Intrauterine growth restriction
- Placenta previa
- Mothers with cardiac disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University Children's Hospital
Cairo, Egypt
Related Publications (5)
Katheria AC, Wozniak M, Harari D, Arnell K, Petruzzelli D, Finer NN. Measuring cardiac changes using electrical impedance during delayed cord clamping: a feasibility trial. Matern Health Neonatol Perinatol. 2015 May 22;1:15. doi: 10.1186/s40748-015-0016-3. eCollection 2015.
PMID: 27057332BACKGROUNDChopra A, Thakur A, Garg P, Kler N, Gujral K. Early versus delayed cord clamping in small for gestational age infants and iron stores at 3 months of age - a randomized controlled trial. BMC Pediatr. 2018 Jul 18;18(1):234. doi: 10.1186/s12887-018-1214-8.
PMID: 30021580BACKGROUNDHsu KH, Wu TW, Wang YC, Lim WH, Lee CC, Lien R. Hemodynamic reference for neonates of different age and weight: a pilot study with electrical cardiometry. J Perinatol. 2016 Jun;36(6):481-5. doi: 10.1038/jp.2016.2. Epub 2016 Feb 18.
PMID: 26890553BACKGROUNDMercer JS, Erickson-Owens DA, Collins J, Barcelos MO, Parker AB, Padbury JF. Effects of delayed cord clamping on residual placental blood volume, hemoglobin and bilirubin levels in term infants: a randomized controlled trial. J Perinatol. 2017 Mar;37(3):260-264. doi: 10.1038/jp.2016.222. Epub 2016 Dec 8.
PMID: 27929530BACKGROUNDSoliman RM, Elgendy MM, Said RN, Shaarawy BI, Helal OM, Aly H. A Randomized Controlled Trial of a 30- versus a 120-Second Delay in Cord Clamping after Term Birth. Am J Perinatol. 2024 Apr;41(6):739-746. doi: 10.1055/a-1772-4543. Epub 2022 Feb 15.
PMID: 35170013DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reem Mahmoud
Cairo University Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics
Study Record Dates
First Submitted
April 18, 2020
First Posted
April 24, 2020
Study Start
January 21, 2020
Primary Completion
March 31, 2020
Study Completion
March 31, 2020
Last Updated
April 24, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share