An interventional study of Delayed cord clamping in Cardiac Output, High and Cardiac Output, Low, sponsored by Cairo University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2020-04-24.
Sponsored by Cairo University · Not applicable, Interventional, and Basic science
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.
The study will include full term infants delivered via cesarean section. Written informed consent for participation in the study will be obtained from parents prior to delivery. Newborns will be randomly assigned into two groups according to the duration of cord clamping: Group 1: the cord will be clamped at 30 seconds, and Group 2: the cord will be clamped at 120 seconds of life. Stopwatch will be started when infants buttocks (or head if breech) are delivered from the uterus. The time elapsed will be counted aloud by the investigator in 10-second intervals. During this time, the infant will be held in linen on the mothers legs. Care will be taken not to apply traction on the cord. Milking of the cord will not be allowed. Immediately after resuscitation, infants will be attached to the leads of the electrical cardiometry device. Device output will be imported at 5, 10, and 15 minutes after birth in both groups. A follow up measurement will be imported later at 24 hours of age. In addition, a peripheral blood sample will be obtained at 24 hours of age for assessment of hemoglobin, glucose and bilirubin concentrations. .
The calculated sample size is 31 newborns in each group. This number will be adequate to detect an effect size of 10% in the mean cardiac output between the two groups with 95% confidence and 80% power. The study plans to recruit 34 infants in each group (10% attrition rate).
94 studies on the registry are indexed under Cardiac Output, Low; 15 are open to participants now.
This study's enrollment of 68 is close to the median of 65 across 46 interventional studies indexed under Cardiac Output, Low.
Browse Cardiac Output, Low studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Infants in this group will receive delayed cord clamping for 30 seconds.
Procedure: Delayed cord clamping
Infants in this group will receive delayed cord clamping for 120 seconds.
Procedure: Delayed cord clamping
The umbilical cord will be clamped after specific time intervals
Cardiac output
Data imported from the electrical cardiometry device
Time frame: at 15 minutes
Stroke volume
Data imported from the electrical cardiometry device
Time frame: at 15 minutes
Cardiac index
Data imported from the electrical cardiometry device
Time frame: at 15 minutes
Index of contractility
Data imported from the electrical cardiometry device
Time frame: at 15 minutes
Heart rate
Data imported from the electrical cardiometry device
Time frame: at 15 minutes
Oxygen saturation
Data imported from the electrical cardiometry device
Time frame: at 15 minutes
Hemoglobin concentration
Blood sample will be obtained an analyzed
Time frame: At 24 hours
Serum glucose concentration
Blood sample will be obtained an analyzed
Time frame: At 24 hours
Serum bilirubin concentration
Blood sample will be obtained an analyzed
Time frame: At 24 hours
Plan to share: No
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Cairo University