Cord Clamping Level Above or Below Mother's Perineum

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cord Clamping Level Above or Below Mother's Perineum

Conditions
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Delayed Cord Clamping, Pre-term Birth

Intervention / Treatment
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* Procedure: Delayed cord clamping above the perineum
* Procedure: Delayed cord clamping below the perineum


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Delayed cord clamping above the perineum<br> | Procedure: Delayed cord clamping above the perineum<br>* 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.<br>|
| Active Comparator: Delayed cord clamping below the perineum<br> | Procedure: Delayed cord clamping below the perineum<br>* The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematocrit Level |  | 24 hours after delivery | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pre-term birth, delayed cord clamping, skin to skin