Trial Outcomes & Findings for Cord Clamping Level Above or Below Mother's Perineum (NCT NCT02659605)
NCT ID: NCT02659605
Last Updated: 2022-02-02
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
103 participants
Primary outcome timeframe
24 hours after delivery
Results posted on
2022-02-02
Participant Flow
103 subjects were consented, but 29 were determined to be ineligible prior to randomization (that is, 29 did not start the study).
Participant milestones
| Measure |
Delayed Cord Clamping Above the Perineum
Delayed cord clamping above the perineum: After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant.
|
Delayed Cord Clamping Below the Perineum
Delayed cord clamping below the perineum: The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
34
|
|
Overall Study
COMPLETED
|
31
|
30
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cord Clamping Level Above or Below Mother's Perineum
Baseline characteristics by cohort
| Measure |
Delayed Cord Clamping Above the Perineum
n=31 Participants
Delayed cord clamping above the perineum: After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant.
|
Delayed Cord Clamping Below the Perineum
n=30 Participants
Delayed cord clamping below the perineum: The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.4 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
26.8 years
STANDARD_DEVIATION 5.2 • n=7 Participants
|
27.1 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
less than 25 kg/m^2
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
greater than or equal to 25 kg/m^2 and below 30 kg
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
greater than or equal to 30 kg/m^2
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Parity
|
1.7 # previous pregnancies carried to term
STANDARD_DEVIATION 1.5 • n=5 Participants
|
1.2 # previous pregnancies carried to term
STANDARD_DEVIATION 1.2 • n=7 Participants
|
1.4 # previous pregnancies carried to term
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Insurance
none/self-pay
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Insurance
Medicaid
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Insurance
private
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Prenatal care
prenatal care
|
30 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Prenatal care
no prenatal care
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Induced
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Gestational age in weeks
|
35.3 weeks
STANDARD_DEVIATION 1.2 • n=5 Participants
|
34.6 weeks
STANDARD_DEVIATION 1.7 • n=7 Participants
|
34.9 weeks
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Gestational age greater than or equal to 32 weeks
|
31 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours after deliveryOutcome measures
| Measure |
Delayed Cord Clamping Above the Perineum
n=31 Participants
Delayed cord clamping above the perineum: After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant.
|
Delayed Cord Clamping Below the Perineum
n=30 Participants
Delayed cord clamping below the perineum: The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.
|
|---|---|---|
|
Hematocrit Level
|
51.5 % of blood composed of red blood cells
Standard Deviation 8.4
|
52.6 % of blood composed of red blood cells
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: during the initial hospital stay (1-2 days)Outcome measures
| Measure |
Delayed Cord Clamping Above the Perineum
n=31 Participants
Delayed cord clamping above the perineum: After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant.
|
Delayed Cord Clamping Below the Perineum
n=30 Participants
Delayed cord clamping below the perineum: The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.
|
|---|---|---|
|
Number of Participants With Infants Who Were Admitted to the Neonatal Intensive Care Unit (NICU)
|
21 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: during the initial hospital stay (1-2 days)Outcome measures
| Measure |
Delayed Cord Clamping Above the Perineum
n=31 Participants
Delayed cord clamping above the perineum: After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant.
|
Delayed Cord Clamping Below the Perineum
n=30 Participants
Delayed cord clamping below the perineum: The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.
|
|---|---|---|
|
Number of Participants With Infants Who Received Phototherapy
|
14 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: during the initial hospital stay (1-2 days)Outcome measures
| Measure |
Delayed Cord Clamping Above the Perineum
n=31 Participants
Delayed cord clamping above the perineum: After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant.
|
Delayed Cord Clamping Below the Perineum
n=30 Participants
Delayed cord clamping below the perineum: The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.
|
|---|---|---|
|
Number of Participants With Infants Who Received Blood Transfusion
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 minute after birthThe Apgar score is a method to quickly summarize the health of newborn children. The Apgar score is determined by evaluating the newborn baby on five simple criteria (Appearance, Pulse, Grimace, Activity, Respiration) on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10, which zero associated with worse outcomes.
Outcome measures
| Measure |
Delayed Cord Clamping Above the Perineum
n=31 Participants
Delayed cord clamping above the perineum: After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant.
|
Delayed Cord Clamping Below the Perineum
n=30 Participants
Delayed cord clamping below the perineum: The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.
|
|---|---|---|
|
Apgar Score at 1 Minute
|
7.8 score
Standard Deviation 1.3
|
7.9 score
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 5 minutes after birthThe Apgar score is a method to quickly summarize the health of newborn children. The Apgar score is determined by evaluating the newborn baby on five simple criteria (Appearance, Pulse, Grimace, Activity, Respiration) on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10, which zero associated with worse outcomes.
Outcome measures
| Measure |
Delayed Cord Clamping Above the Perineum
n=31 Participants
Delayed cord clamping above the perineum: After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant.
|
Delayed Cord Clamping Below the Perineum
n=30 Participants
Delayed cord clamping below the perineum: The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.
|
|---|---|---|
|
Apgar Score at 5 Minutes
|
8.7 score
Standard Deviation 0.6
|
8.6 score
Standard Deviation 0.9
|
Adverse Events
Delayed Cord Clamping Above the Perineum
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Delayed Cord Clamping Below the Perineum
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. Pamela D. Berens
The University of Texas Health Science Center at Houston
Phone: (713) 500-6471
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place