Trial Outcomes & Findings for Umbilical Cord Clamping: What Are the Benefits (NCT NCT03878602)
NCT ID: NCT03878602
Last Updated: 2021-04-19
Results Overview
It will be measured the change of heart rate (HR)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
142 participants
Primary outcome timeframe
5 minutes and 10 minutes after birth
Results posted on
2021-04-19
Participant Flow
Participant milestones
| Measure |
Immediate Clamping
Newborns will be subjected to umbilical cord immediate clamping
Immediate umbilical cord clamping: Umbilical cord will be clamped immediately after the birth of the newborn
|
Delayed Clamping
Newborns will be subjected to umbilical cord delayed clamping
Delayed umbilical cord clamping: Umbilical cord will be clamped after 1 min after the birth of the newborn
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
67
|
|
Overall Study
COMPLETED
|
66
|
66
|
|
Overall Study
NOT COMPLETED
|
9
|
1
|
Reasons for withdrawal
| Measure |
Immediate Clamping
Newborns will be subjected to umbilical cord immediate clamping
Immediate umbilical cord clamping: Umbilical cord will be clamped immediately after the birth of the newborn
|
Delayed Clamping
Newborns will be subjected to umbilical cord delayed clamping
Delayed umbilical cord clamping: Umbilical cord will be clamped after 1 min after the birth of the newborn
|
|---|---|---|
|
Overall Study
cord blood donation
|
7
|
1
|
|
Overall Study
incomplete data collection
|
2
|
0
|
Baseline Characteristics
Umbilical Cord Clamping: What Are the Benefits
Baseline characteristics by cohort
| Measure |
Control Group
n=66 Participants
Newborns will be subjected to umbilical cord immediate clamping
Immediate umbilical cord clamping: Umbilical cord will be clamped immediately after the birth of the newborn
|
Study Group
n=66 Participants
Newborns will be subjected to umbilical cord delayed clamping
Delayed umbilical cord clamping: Umbilical cord will be clamped after 1 min after the birth of the newborn
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
66 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
66 participants
n=5 Participants
|
66 participants
n=7 Participants
|
132 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
66 participants
n=5 Participants
|
66 participants
n=7 Participants
|
132 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 minutes and 10 minutes after birthIt will be measured the change of heart rate (HR)
Outcome measures
| Measure |
Control Group
n=66 Participants
Newborns will be subjected to umbilical cord immediate clamping
Immediate umbilical cord clamping: Umbilical cord will be clamped immediately after the birth of the newborn
|
Study Group
n=66 Participants
Newborns will be subjected to umbilical cord delayed clamping
Delayed umbilical cord clamping: Umbilical cord will be clamped after 1 min after the birth of the newborn
|
|---|---|---|
|
Change of Heart Rate After Delayed Umbilical Clamping
5 minutes
|
164 bpm
Standard Deviation 18
|
157 bpm
Standard Deviation 15
|
|
Change of Heart Rate After Delayed Umbilical Clamping
10 minutes
|
163 bpm
Standard Deviation 15
|
155 bpm
Standard Deviation 13
|
PRIMARY outcome
Timeframe: 5 minutes and 10 minutes after birthSaturation change (SpO2)
Outcome measures
| Measure |
Control Group
n=66 Participants
Newborns will be subjected to umbilical cord immediate clamping
Immediate umbilical cord clamping: Umbilical cord will be clamped immediately after the birth of the newborn
|
Study Group
n=66 Participants
Newborns will be subjected to umbilical cord delayed clamping
Delayed umbilical cord clamping: Umbilical cord will be clamped after 1 min after the birth of the newborn
|
|---|---|---|
|
Change of Saturation After Delayed Umbilical Clamping
5 minutes
|
88.98 percent of saturated hemoglobin
Standard Deviation 7.027
|
89.169 percent of saturated hemoglobin
Standard Deviation 7.453
|
|
Change of Saturation After Delayed Umbilical Clamping
10 minutes
|
95.238 percent of saturated hemoglobin
Standard Deviation 3.976
|
96.046 percent of saturated hemoglobin
Standard Deviation 3.346
|
PRIMARY outcome
Timeframe: 5 minutes after birthTemperature change (T)
Outcome measures
| Measure |
Control Group
n=66 Participants
Newborns will be subjected to umbilical cord immediate clamping
Immediate umbilical cord clamping: Umbilical cord will be clamped immediately after the birth of the newborn
|
Study Group
n=66 Participants
Newborns will be subjected to umbilical cord delayed clamping
Delayed umbilical cord clamping: Umbilical cord will be clamped after 1 min after the birth of the newborn
|
|---|---|---|
|
Change of Temperature After Delayed Umbilical Clamping
|
36.60 degrees Celsius
Standard Deviation 0.64
|
36.64 degrees Celsius
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: 120 minutes after birthhemo gluco test (HGT)
Outcome measures
| Measure |
Control Group
n=66 Participants
Newborns will be subjected to umbilical cord immediate clamping
Immediate umbilical cord clamping: Umbilical cord will be clamped immediately after the birth of the newborn
|
Study Group
n=66 Participants
Newborns will be subjected to umbilical cord delayed clamping
Delayed umbilical cord clamping: Umbilical cord will be clamped after 1 min after the birth of the newborn
|
|---|---|---|
|
Misuration of the Hemo Gluco Test After Delayed Umbilical Clamping
|
60.32 mg/dl
Standard Deviation 9.937
|
56.02 mg/dl
Standard Deviation 17.101
|
SECONDARY outcome
Timeframe: 72 hours of lifehematocrit (Ht)
Outcome measures
| Measure |
Control Group
n=66 Participants
Newborns will be subjected to umbilical cord immediate clamping
Immediate umbilical cord clamping: Umbilical cord will be clamped immediately after the birth of the newborn
|
Study Group
n=66 Participants
Newborns will be subjected to umbilical cord delayed clamping
Delayed umbilical cord clamping: Umbilical cord will be clamped after 1 min after the birth of the newborn
|
|---|---|---|
|
Misuration of the Hematocrit After Delayed Umbilical Clamping
|
51.56 percent of occupied blood volume
Standard Deviation 6.929
|
56.71 percent of occupied blood volume
Standard Deviation 6.663
|
SECONDARY outcome
Timeframe: 72 hours of lifebilirubin
Outcome measures
| Measure |
Control Group
n=66 Participants
Newborns will be subjected to umbilical cord immediate clamping
Immediate umbilical cord clamping: Umbilical cord will be clamped immediately after the birth of the newborn
|
Study Group
n=66 Participants
Newborns will be subjected to umbilical cord delayed clamping
Delayed umbilical cord clamping: Umbilical cord will be clamped after 1 min after the birth of the newborn
|
|---|---|---|
|
Misuration of the Bilirubin After Delayed Umbilical Clamping
|
7.06 mg/dl
Standard Deviation 2.76
|
8.54 mg/dl
Standard Deviation 2.90
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Study Group
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
Dr.Giuseppe De Bernardo
Ospedale Buon Consiglio Fatebenefratelli
Phone: 3357441303
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place