Trial Outcomes & Findings for Cardiac and Cerebral Hemodynamics With Umbilical Cord Milking Compared With Early Cord Clamping (NCT NCT03621956)

NCT ID: NCT03621956

Last Updated: 2024-07-08

Results Overview

Cerebral oxygenation derived from skeletal muscle oxygen saturation (StO2) measured by near-infrared spectroscopy (NIRS). Once the newborn is delivered, receives the intervention (UCM or ECC), and is stabilized during resuscitation, a NIRS sensor (Fore-Sight, CAS Medical, Branford, CT) will be placed on the right forehead within 10 minutes of the newborn being placed on the resuscitation bed.

Recruitment status

COMPLETED

Study phase

Target enrollment

34 participants

Primary outcome timeframe

birth to 10 minutes of life

Results posted on

2024-07-08

Participant Flow

Participant milestones

Participant milestones
Measure	Umbilical Cord Milking At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 15-20 seconds. Umbilical Cord Milking: At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 15-20 seconds.	Early Cord Clamping The umbilical cord is clamped within 30 seconds of delivery. Early Cord Clamping: The umbilical cord is clamped within 30 seconds of delivery.
Overall Study STARTED	15	19
Overall Study COMPLETED	15	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Umbilical Cord Milking n=15 Participants At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 15-20 seconds. Umbilical Cord Milking: At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 15-20 seconds.	Early Cord Clamping n=19 Participants The umbilical cord is clamped within 30 seconds of delivery. Early Cord Clamping: The umbilical cord is clamped within 30 seconds of delivery.	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=15 Participants	19 Participants n=19 Participants	34 Participants n=34 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=15 Participants	0 Participants n=19 Participants	0 Participants n=34 Participants
Age, Categorical >=65 years	0 Participants n=15 Participants	0 Participants n=19 Participants	0 Participants n=34 Participants
Age, Continuous	38.13 Gestational Age in weeks STANDARD_DEVIATION 1.56 • n=15 Participants	38.95 Gestational Age in weeks STANDARD_DEVIATION 1.72 • n=19 Participants	38.54 Gestational Age in weeks STANDARD_DEVIATION 0.41 • n=34 Participants
Sex: Female, Male Female	6 Participants n=15 Participants	10 Participants n=19 Participants	16 Participants n=34 Participants
Sex: Female, Male Male	9 Participants n=15 Participants	9 Participants n=19 Participants	18 Participants n=34 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	10 participants n=15 Participants	0 participants n=19 Participants	10 participants n=34 Participants
Region of Enrollment United States	5 participants n=15 Participants	19 participants n=19 Participants	24 participants n=34 Participants

PRIMARY outcome

Timeframe: birth to 10 minutes of life

Outcome measures

Outcome measures
Measure	Umbilical Cord Milking n=15 Participants At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 15-20 seconds.	Early Cord Clamping n=19 Participants The umbilical cord is clamped within 30 seconds of delivery.
StO2 in the First 10 Minutes of Life	70 percent Standard Deviation 7.15	74.5 percent Standard Deviation 2.17

SECONDARY outcome

Timeframe: Birth to 10 minutes of life

Heart rate was recorded from the electrocardiogram monitor.

Outcome measures

Outcome measures
Measure	Umbilical Cord Milking n=15 Participants At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 15-20 seconds.	Early Cord Clamping n=19 Participants The umbilical cord is clamped within 30 seconds of delivery.
Heart Rate at 10 Minutes	152 Beats per minute Standard Deviation 12.76	160 Beats per minute Standard Deviation 12.99

Adverse Events

Umbilical Cord Milking

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Early Cord Clamping

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anup Katheria, M.D.

Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns

Phone: 858-939-4170

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place