Delayed Cord Clamping, Pre-term Birth
Conditions
Keywords
pre-term birth, delayed cord clamping, skin to skin
Brief summary
The purpose of this study is to determine if delayed cord clamping above the perineum has an effect on neonatal hematocrit when compared to delayed cord clamping below the perineum in pre-term spontaneous vaginal deliveries.
Detailed description
This study will compare the difference in neonatal hematocrit with delayed cord clamping above vs. below the perineum, in infants who are born via pre-term spontaneous vaginal deliveries that are vigorous at delivery. Delayed cord clamping below the perineum is an accepted clinical practice in obstetrics and gynecology; however, delayed cord clamping above the perineum has not yet been studied in preterm infants. Delayed cord clamping above the perineum will provide the benefit of immediate skin-to-skin contact between the mother and her newborn. Patients will have delayed cord clamping performed for 60-75 seconds either below the maternal perineum or while the infant is placed on the mother's abdomen. At approximately 24 hours after delivery (at the time of infant heel stick for routine, state-mandated screening tests), a small additional amount of blood will be collected to evaluate newborn hematocrit.
Interventions
PROCEDUREDelayed 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.
PROCEDUREDelayed 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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Singleton intrauterine pregnancies at least 30 weeks gestation but less than 37 weeks gestation
Exclusion criteria
* Acute febrile illnesses or chronic medical problems such as hypertension, diabetes mellitus, renal disease, medically-managed seizure disorders * Pregnancy-related complications such as pre-eclampsia, intrauterine growth restriction, chromosomal/anatomical abnormalities, and placental abruption * Infants who are not anticipated to undergo spontaneous vaginal delivery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematocrit Level | 24 hours after delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Infants Who Were Admitted to the Neonatal Intensive Care Unit (NICU) | during the initial hospital stay (1-2 days) | — |
| Number of Participants With Infants Who Received Phototherapy | during the initial hospital stay (1-2 days) | — |
| Number of Participants With Infants Who Received Blood Transfusion | during the initial hospital stay (1-2 days) | — |
| Apgar Score at 1 Minute | 1 minute after birth | The 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. |
| Apgar Score at 5 Minutes | 5 minutes after birth | The 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. |
Countries
United States
Participant flow
Pre-assignment details
103 subjects were consented, but 29 were determined to be ineligible prior to randomization (that is, 29 did not start the study).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 31 |
| 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. | 30 |
| Total | 61 |
Baseline characteristics
| Characteristic | Delayed Cord Clamping Above the Perineum | Delayed Cord Clamping Below the Perineum | Total |
|---|---|---|---|
| Age, Continuous | 27.4 years STANDARD_DEVIATION 6 | 26.8 years STANDARD_DEVIATION 5.2 | 27.1 years STANDARD_DEVIATION 5.6 |
| Body Mass Index (BMI) greater than or equal to 25 kg/m^2 and below 30 kg | 9 Participants | 7 Participants | 16 Participants |
| Body Mass Index (BMI) greater than or equal to 30 kg/m^2 | 18 Participants | 15 Participants | 33 Participants |
| Body Mass Index (BMI) less than 25 kg/m^2 | 4 Participants | 8 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 10 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 17 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Gestational age greater than or equal to 32 weeks | 31 Participants | 26 Participants | 57 Participants |
| Gestational age in weeks | 35.3 weeks STANDARD_DEVIATION 1.2 | 34.6 weeks STANDARD_DEVIATION 1.7 | 34.9 weeks STANDARD_DEVIATION 1.7 |
| Induced | 20 Participants | 19 Participants | 39 Participants |
| Insurance Medicaid | 26 Participants | 20 Participants | 46 Participants |
| Insurance none/self-pay | 1 Participants | 1 Participants | 2 Participants |
| Insurance private | 4 Participants | 9 Participants | 13 Participants |
| Parity | 1.7 # previous pregnancies carried to term STANDARD_DEVIATION 1.5 | 1.2 # previous pregnancies carried to term STANDARD_DEVIATION 1.2 | 1.4 # previous pregnancies carried to term STANDARD_DEVIATION 1.4 |
| Prenatal care no prenatal care | 1 Participants | 2 Participants | 3 Participants |
| Prenatal care prenatal care | 30 Participants | 28 Participants | 58 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 13 Participants | 30 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 13 Participants | 23 Participants |
| Race (NIH/OMB) White | 4 Participants | 4 Participants | 8 Participants |
| Region of Enrollment United States | 31 Participants | 30 Participants | 61 Participants |
| Sex: Female, Male Female | 31 Participants | 30 Participants | 61 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 30 |
| other Total, other adverse events | 0 / 31 | 0 / 30 |
| serious Total, serious adverse events | 0 / 31 | 0 / 30 |
Outcome results
Primary
Hematocrit Level
Time frame: 24 hours after delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delayed Cord Clamping Above the Perineum | Hematocrit Level | 51.5 % of blood composed of red blood cells | Standard Deviation 8.4 |
| Delayed Cord Clamping Below the Perineum | Hematocrit Level | 52.6 % of blood composed of red blood cells | Standard Deviation 7.3 |
p-value: 0.572Student's t-test
Secondary
Apgar Score at 1 Minute
The 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.
Time frame: 1 minute after birth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delayed Cord Clamping Above the Perineum | Apgar Score at 1 Minute | 7.8 score | Standard Deviation 1.3 |
| Delayed Cord Clamping Below the Perineum | Apgar Score at 1 Minute | 7.9 score | Standard Deviation 1.5 |
p-value: 0.728Student's t-test
Secondary
Apgar Score at 5 Minutes
The 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.
Time frame: 5 minutes after birth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delayed Cord Clamping Above the Perineum | Apgar Score at 5 Minutes | 8.7 score | Standard Deviation 0.6 |
| Delayed Cord Clamping Below the Perineum | Apgar Score at 5 Minutes | 8.6 score | Standard Deviation 0.9 |
p-value: 0.584Student's t-test
Secondary
Number of Participants With Infants Who Received Blood Transfusion
Time frame: during the initial hospital stay (1-2 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delayed Cord Clamping Above the Perineum | Number of Participants With Infants Who Received Blood Transfusion | 1 Participants |
| Delayed Cord Clamping Below the Perineum | Number of Participants With Infants Who Received Blood Transfusion | 2 Participants |
p-value: 0.612Student's t-test
Secondary
Number of Participants With Infants Who Received Phototherapy
Time frame: during the initial hospital stay (1-2 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delayed Cord Clamping Above the Perineum | Number of Participants With Infants Who Received Phototherapy | 14 Participants |
| Delayed Cord Clamping Below the Perineum | Number of Participants With Infants Who Received Phototherapy | 13 Participants |
p-value: 0.886Student's t-test
Secondary
Number of Participants With Infants Who Were Admitted to the Neonatal Intensive Care Unit (NICU)
Time frame: during the initial hospital stay (1-2 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delayed Cord Clamping Above the Perineum | Number of Participants With Infants Who Were Admitted to the Neonatal Intensive Care Unit (NICU) | 21 Participants |
| Delayed Cord Clamping Below the Perineum | Number of Participants With Infants Who Were Admitted to the Neonatal Intensive Care Unit (NICU) | 21 Participants |
p-value: 0.849Student's t-test