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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delayed cord clamping above the perineum | Experimental |
| |
| Delayed cord clamping below the perineum | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delayed cord clamping above the perineum | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hematocrit Level | 24 hours after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Berens, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26651542 | Background | Mansaray A, Yetman R, Berens P. Effect of Delayed Cord Clamping Above Versus Below the Perineum on Neonatal Hematocrit: A Randomized Controlled Trial. Breastfeed Med. 2015 Dec;10(10):464-7. doi: 10.1089/bfm.2015.0109. |
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103 subjects were consented, but 29 were determined to be ineligible prior to randomization (that is, 29 did not start the study).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Delayed Cord Clamping Below the Perineum |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hematocrit Level | Posted | Mean | Standard Deviation | % of blood composed of red blood cells | 24 hours after delivery |
|
during the initial hospital stay (1-2 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Inability to blind participants and medical staff involved in the delivery. Data for some subjects was not obtained due to systems errors.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pamela D. Berens | The University of Texas Health Science Center at Houston | (713) 500-6471 | Pamela.D.Berens@uth.tmc.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 29, 2016 | Apr 18, 2019 | Prot_000.pdf |
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| Delayed cord clamping below the perineum | Procedure | 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 | during the initial hospital stay (1-2 days) |
| 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. | 1 minute after birth |
| 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. | 5 minutes after birth |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Body Mass Index (BMI) | Count of Participants | Participants |
|
| Parity | Mean | Standard Deviation | # previous pregnancies carried to term |
|
| Insurance | Count of Participants | Participants |
|
| Prenatal care | Count of Participants | Participants |
|
| Induced | Count of Participants | Participants |
|
| Gestational age in weeks | Mean | Standard Deviation | weeks |
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| Gestational age greater than or equal to 32 weeks | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
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| Secondary | Number of Participants With Infants Who Were Admitted to the Neonatal Intensive Care Unit (NICU) | Posted | Count of Participants | Participants | during the initial hospital stay (1-2 days) |
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| Secondary | Number of Participants With Infants Who Received Phototherapy | Posted | Count of Participants | Participants | during the initial hospital stay (1-2 days) |
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| Secondary | Number of Participants With Infants Who Received Blood Transfusion | Posted | Count of Participants | Participants | during the initial hospital stay (1-2 days) |
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|
| 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. | Posted | Mean | Standard Deviation | score | 1 minute after birth |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score | 5 minutes after birth |
|
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | 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. | 0 | 30 | 0 | 30 | 0 | 30 |
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